Posts Tagged Notified Body

JOBS – December, 2013

For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: All below opportunities require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs.  I am awaiting more job descriptions and will keep adding.   Leads appreciated.

ios/ Android Developers – Bay Area, CA
Immediate need for health-IT company.

Senior and Junior Bioinformatics Scientists – San Ramon, CA

An organization near San Ramon, CA, dedicated to leveraging a range of transformational digital medical technologies in medical imaging and information technologies, medical diagnostics, patient monitoring, disease research, drug discovery & biopharmaceutical manufacturing technologies, has an immediate openings for Bioinformatics Scientists at Senior and Junior level.  Below description is for senior role.

Responsibilities: Bioinformatics developer will work with scientists & engineers for development of systems software within medical diagnostics. The position may also develop distributed software application for subsystems that enable the business strategic imperatives.  Essential functions: Develop robust bioinformatics software solutions to support company’s medical diagnostic activities; Work closely with systems teams in requirements gathering & software design; Interact with global teams to promote consistency & maximize synergies across common software platforms; Design & build strong testing infrastructure to minimize dependency on hardware availability; Leverage DFR for software, Agile & Lean software development methodologies to drive reliability upstream into the product development life cycle.

Requirements: MS or Ph.D. in Bioinformatics or Molecular Biology with a minor in Computer Science, Statistics or Computational Biology; 5+ years experience in combining knowledge of chemistry, physics, and/or biology with software engineering; 3+ years experience in programming using Pearl and/or Python; 2+ years experience with SQL, preferably MySQL; 2+ years experience with statistical programming (e.g. R, MATLAB).

Regulatory Affairs Director – Mount Laurel, NJ, & Orangeburg, New York (and another similar opening in Bay Area, CA)
(mention location preference when sending in the CV)

There is an immediate opening for Regulatory Affairs Director in a medical device company with innovative treatment of chronic heart failure built around CCM technology.  RA Director Will be responsible for RA and for Quality systems.

Responsibilities: Domestic & international submissions & approvals for all new & existing products; Assuring compliance with domestic & international quality and regulatory requirements; Assistance with design & implementation of clinical trials to support new & existing products; Represent company with FDA, Notified Body &  international regulatory agencies regarding company’s regulatory strategies & submissions; Determine strategy, content & structure of domestic & international regulatory filings & quality assurance strategies; Maintain quality system & current product documentation & labeling in compliance with new standards, directives & requirements; Assist in design & implementation of clinical studies in support of new & existing products.  Act as liaison with clinical function; Represent the company with all domestic & international regulatory agencies including all verbal & written communication to & from the company; make all final decisions regarding all Quality System related activities; Review all product complaints & ensure timely reporting of those events to domestic & international regulatory agencies as necessary; Review & revise quality system documentations; Schedule, ensure completion of, manage & respond to all audits; Ensure training of employees on Quality Systems Regulation & key international regulations & standards; Manage the program for handling product returns, returned product evaluations (repair/rework, where applicable), complaints & customer feedback in accordance with internal policies and procedures; Maintain ISO 13485:2012 facility registration in accordance with applicable standards; Participate in product development teams on behalf of Regulatory & Quality Systems; Ensure that the Quality Systems function is carried out in accordance with GMP & ISO directives; Prepare &  submit regulatory submissions to obtain approval to conduct domestic & international clinical investigations & to seek regulatory approval to commercialize new & existing devices & their accessories.

Requirements: Bachelor in science / engineering with at least 5 years’ experience in Regulatory/Clinical/Quality area or related experience; Regulatory/Clinical/Quality experience with Class 3 medical device; Regulatory experience in the Implantable field – highly preferable; Excellent working knowledge of domestic & international requirements, regulations & standards applicable to medical electrical devices – highly desirable; Proven experience with at least one complete medical device submission to a EU Notified body and the US FDA involving a device subject to the 60601-1 3rd edition standard; Thorough understanding of the MDD (Medical Device Directive); Previous direct interaction with the FDA & an EU Notified Body; Excellent working understanding of requirements & implementation of Quality Systems compliant with US & international requirements for medical device manufacturers; Previous experience assuring that the Quality Systems function is carried out in accordance with GMP & ISO directives; Ability to analyze & perform commercial risk management in the context of regulatory & quality requirements.

Director of Quality Assurance – Palo Alto, CA

Details to follow.

Senior Manager/ Director of Mechanical Engineering – San Jose, CA

There is an immediate opening for hands-on Director of R&D Mechanical Engineering in an early stage company developing a novel approach for the oral delivery of large drug molecules.  This position will be responsible for building the team and effectively leading multi-project R&D efforts of the organization through technical expertise, interpersonal skills & a clear vision for execution.  Stock options and cutting edge technology makes it highly attractive opportunity for the right candidate.

Responsibilities: Manage resources to accomplish multi-project product research & development; Provide Mechanical Engineering support to meet R&D objectives; Remain current on developments in field(s) of expertise and industry trends; Actively pursue development of corporate IP; Identify future product opportunities; Develop plans & analyses for execution and review with leadership team; Maintain & update appropriate controlled documentation; Mentor junior staff members.

Skills & Experience: Demonstrated leadership of technical teams in medical device field; aptitude for & mastery of Mechanical Engineering principles; problem solving skills in a multidisciplinary environment; Proficient with statistical analysis for engineering and manufacturing; ability to work closely with team members across engineering & non-engineering disciplines such as biochemistry, physiology, pharmacology & chemistry; Knowledge of plastic manufacturing processes including injection molding, thermoforming, casting, machining, extrusion etc.; Knowledge of metals & alloys used in medical devices and processing techniques such as brazing, laser welding & cutting, electropolishing, electroplating, machining etc.; Deep experience in polymer processing, catheter design & fabrication, including knowledge of polymer joining, fusing, die cutting, adhesives etc.; Knowledge of biomaterials & coatings suitable for implantation; Knowledge of packaging & sterilization techniques; ability to interface effectively with professionals in the medical and biological sciences; knowledge of sound design principles, regulatory requirements, and product and process validation procedures; proficiency with computer aided design software & hardware. Formal training on systems & software is desired.

Also required: Bachelor’s degree or higher in Mechanical Engineering; 10+ years experience in engineering and product development with demonstrated capability & thorough understanding of the medical device product development process; Three years minimum direct personnel management & related project leadership experience; ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines & develop, monitor and live within budgets as well as ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building.

Director Quality Engineering – San Jose, CA

There is an exciting opportunity for Director Quality Engineering with strong capability and experience developing quality innovative medical devices.  This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution.

Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members

Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired.

Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.  Must be skilled at delegation, follow-up, and team building.

Patent Attorney – Sunnyvale, CA

Innovative medical device company with a broad line of product portfolio, has an opening for Senior Patent Attorney for VP level position.  Must have 15+ years of medical device and biotech patent prosecution experience in a law firm.

Research Engineer – San Francisco, CA

A company that has developed advanced consumer health sensing technology, has an immediate opening for research engineer.  Responsibilities include, research and implement cutting edge physiological sensors and algorithms and work closely with research and device teams to integrate research into company’s consumer product portfolio.

Requirements: MS or PhD in biomedical engineering, electrical engineering, or related discipline; Minimum of 2-4 years (or academic equivalent) experience in physiological data collection, interpretation and analysis; Proficient in common signal processing techniques including time series analysis, adaptive filters, and noise cancellation; Demonstrated ability in a scientific computing language (e.g. Python, R, Matlab).
Also preferred: Experience developing algorithms for  physiological signals such as heart rate, temperature, perspiration or body motion accelerometry; Proficiency with machine learning and statistical modeling; Experience with data handling and storage, e.g. NoSQL database systems

Software Developers – SF Bay Area (contract, part-time)

Big data and machines are revolutionizing the way we operate. A software company that provides innovative, modular, scalable and world class solutions, in this industrial-internet paradigm, by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is now scaling in pre-funding stage. Some of the clients include Cisco Systems, Applied Mateirals, Huawei, Agilent, HP, Foxconn, Fletronics, and Sanmina that are using this software to transform their engineering and manufacturing operations. The company is expanding core engineering and product development team and looking for high caliber, senior software developers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.

Responsibilities include: Being involved in all stages of SDLC including analysis, design, implementation, testing, documentation, and release; Participate in multiple projects with changing requirements; and Maintain contact with clients/ partners to provide solution support and updates.

Requirements include: 4-6 years of software development experience; Software Development experience; ASP.NET with MVC, JQuery; Comfortable in data modeling, developing stored procedures, and triggers; and Readiness to learn new technologies quickly. Windows Workflow Communication Foundation 4.0; Biztalk RFID server skills; Windows Mobile Development experience; and Exposure to Windows Azure.

The position is located in the San Francisco Bay Area. Telecommute is okay but may need to attend client team meetings. Duration: 6-12 months to full-time. Terms: 1099, corp-to-corp, contract-to-hire, no visa sponsorships but OPT visa may be ok. Pay: rate negotiable. Open to considering excellent part-time candidates.


Twitter For Job Search

Twitter For Job Search (Photo credit: FunnyBiz)

, , , , , , , , , , , , , ,

Leave a comment

Changing Medical Device Regulations in Europe

Dr. Martine Dehlinger-Kremer, Global Vice President, Regulatory Affairs at Research Pharmaceutical Services, talked about Changing Medical Device Regulations in Europe, at event.  Dr. Dhlinger-Kremer has over 27 years of experience in medical device regulatory affairs, progressively in higher leadership roles, including as VP of International and Global Regulatory Affairs as well as VP of Global Medical Affairs, in global CROs.

Definition and History of Medical Device Regulations in Europe

Medical devices include diverse group of products, from eye glasses to pacemakers.  Dehlinger-Kremer began by sharing the history of regulations.  Some European countries set up specific regulations for medical devices in 1976.  By 1980s, there were specific pre-marketing approval requirements in most Western EU countries, but requirements were different, in different countries.  In 1990s, there was a process to harmonize these requirements by introducing conformity assessment procedures, certain mandatory essential requirements, and by introducing of CE marking in 1995.  Device Directive in 2007, added requirements for software and more stringent requirements for clinical data.

Current system of Medical Device Regulations

Currently, there are 3 directives (only one apply to one product), applicable in 33 participating countries.  These are, Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Devices Directive (IVDD).  Examples of medical devices include medical gloves, syringes, blood collection containers and it refers to any instrument, apparatus, appliance, software or material, whether used alone or in combination, for diagnostic or therapeutic purposes.  Active implantable medical device refers to any device, totally or partially introduced, into the human body or by medical intervention, with the intention to be left there after the procedure and examples include pacemakers, cardiac defibrillators, bladder stimulators, cochlear implants and so on.  Examples of in vitro diagnostic devices include reagents for blood group determination or for detecting infectious or hereditary diseases and so on and refer to reagent, reagent product, instrument or system, used in vitro, for the examination of specimens.

CA or Competent Authorities is the EU equivalent of USFDA.  The CA has a final say in authorizing clinical trials, give a final classification decision, in case of a dispute, final authority over registration of manufacturers, and over safety measures.  The CA appoints NB or Notified Body and NB is responsible for performance of audits, for issuing Certificates of Conformity, and for keeping CA informed.   Current process to bring any medical device to market in EU, begins with the determination of classification and determination of conformity assessment.  A technical file and design dossier needs to be set up, an authorized representative is appointed, clinical evaluation is performed, NB inspects the quality system when required, a declaration of conformity is prepared, and the device is registered and labeled.  Post market surveillance should include, risk management system (ISO 14971), with proper reporting of all adverse events.

Challenges with the existing system 

Several new changes are to be introduced do deal with various challenges that exist with the existing system.  Some of the challenges of the current system include, Lack of harmonization and cooperation between MS especially regarding the designation and monitoring of NBs, Variation regarding quality and depth of the conformity assessment performed by NBs, Lack of transparency, including availability of data to public, traceability of devices; Access to external expertise; and Regulatory gaps or uncertainties with regard to certain products not covered by existing regulations, including cosmetic and nanotechnology products.

The Poly Implant Prothèses (PIP) Breast Implant Scandal that happened in 2012 was one of the major drivers for change.  Rheinland (Germany) gave a quality certificate to the production process used by the company until March 2010. However, this didn’t apply to the type of silicone used.  PIP used in the implants was of in-house manufactured, industrial-grade quality, instead of medical-grade silicone that is used in the majority of the implants.  Almost 400,000 women globally and 100,000 across Europe, suffered from the unsafe implants.  Now the EU is proposing updated regulations on medical devices in order to ensure these products are safe, and can be freely and fairly traded throughout the EU.

Proposed New Changes & Regulations

Proposal for changes was introduced in September, 2012 and is expected to be adopted by 2015.  The aim of the new changes is to overcome current problems and gaps, strengthen patient safety, and introduce regulatory framework to be supportive of innovation.  MDCG or Medical Device Coordinating Group will be the new group to oversee all EU countries and achieve harmonized interpretation and practice.  There will be greater scrutiny of Class III devices.  Member states will continue to appoint Notified Bodies but there will be strict criteria for the appointment and they will be made through joint assessments.  Main stakeholders will now include, 1) CA or Competent Authorities that will designate and monitor NBs.  2) Notified Bodies that will be supported by MDCG and Commission and will conduct review process, maintain extended databases, conduct safety surveillance and safety measures, and assess manufacture compliance.  They will be accredited by CA, the staff will require higher accreditation, and will be required to rotate.  3) Medical Device Coordinating Group or MDCG will comprise of experts who will be deeply involved in conformity assessment, particularly of high risk devices, and will advice the Commission.  4) The Commission will issue detailed guidance documents and will provide technical, scientific, and logistical support to other bodies.  5) EU Reference Laboratory, appointed by the Commission, will provide input on reference materials, on specific hazards and technologies and will contribute to continuing development of standards.

A new term, Economic Operator is introduced and refers to authorized representative, manufacturer, importer, and distributor.  Another new term introduced is QP or Qualified Person and all manufacturers and/or authorized representatives will be required to have at least one QP who possesses expert knowledge in the field of medical devices and is a go to contact person, in case of problems.  There will be some changes in classification of MD or medical devices.  For instance, some previously classified Class IIB devices, like hip, shoulder, knee implants will be classified as Class III devices.   IVD devices will still be classified in 4 classes, from A representing lowest risk to D representing highest risk.  But there will be a change from list-based system to risk-rule based classification system, which will work similar to system for MDs.

Further changes are also introduced with respect to clinical trials, that include timelines, introduction of a Single Contact Point for CTA (clinical trial assessment), and a new concept of “sponsor” is introduced that is aligned with CTs on medicinal products.   The sponsor will be required to notify the Member States concerned, within stipulated time, of possible adverse events.  There will be simplified approval process for multinational trials.  There is introduction of Post Market EU Portal for Reporting of serious post market incidents.  For traceability, manufacturers/ ARs and importers will be required to register themselves and the devices

they place on the EU market in a central European database, supply chain will be tracked by Economic Operators, Unique Device Identification (UDI) will be assigned to the device to allow for traceability, and Implant Card will be provided to the patients.  To increase transparency, manufacturers of class III, C & D devices, will be required to make a summary of safety and efficacy from the clinical data, publicly available.  The Eudamed database will be expanded and will be made available to the public.

The proposed changes are expected to impact the timeline to bring medical devices to market in EU, as they will require additional trials to better document clinical outcome and some delay can happen in receiving the Certificate of Conformity from NB.  However, they are expected to result in greater harmonization across Europe and enhance safety for the patients.

CE marks ("Conformité Européenne" an...

CE marks (“Conformité Européenne” and “China Export”): fraud or joke? (Photo credit: zipckr)



Enhanced by Zemanta

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,


%d bloggers like this: