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Product Expert

Company: TUV SUD America
Location: Peabody
Posted on: January 12, 2020

Job Description:

Product Expert 123983 Full time permanent Professionals 3 - 5 years of experience Medical Devices & Healthcare


Your responsibilities will include, but are not limited to:



- Assessment of Technical Documentation: Perform conformity assessments of regulatory submissions such as Design Dossiers and Technical Documentations to relevant safety principles and standard requirements.
- Auditing (to limited extent): Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Medical Device Single Audit Program (US, Canada, Brazil, Japan, Australia), and International quality system standards (e.g. ISO 13485) as well as internal Notified Body and T V S D America criteria including all related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body.
- Project Management: Provide project management for NAFTA-based customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.
- Communication / Customer Service: Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.







Immediate opening for a Product Expert based either from a home office or one of our offices Peabody MA, New Brighton MN, Alpharetta GA or San Diego CA.


For over 30 years, T V S D has provided market access solutions and expert partnership for medical device manufacturers and suppliers. Our dedicated team of over 500 medical experts, engineers, and doctors, positioned all over the globe, provide assessments that cover the full life cycle of your medical device - including initial product designs, risk management, clinical and regulatory.


We are looking for personable and outgoing individual who will work closely with our medical device customers. This position will be the key contact to proactively provide superior customer service to customers. Your role and responsibilities include assessment of active medical implants per the European Active Implantable Medical Device Directive, Essential Requirements and international standards, including related client and project management. We are looking for a detail-oriented individual with conformity testing experience, ideally within the medical / regulatory field.


T V S D America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.


For more information on applicable equal employment regulations, please refer to the following:


EEO is the Law Poster: www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


EEO is the Law Poster Supplement: www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf


Pay Transparence Policy Statement: www.dol.gov/ofccp/PayTransparencyNondiscrimination.html


This job may be for you if have:


- Minimum BSc degree in biomedical, electrical, or mechanical engineering or equivalent
- Four years work experience in design / product development / manufacturing engineering one of the following medical device product categories: Active Implantable Medical Devices, Orthopedics, Cardivascular Products, Functional Safety and Software
- A relevant Master degree substitutes one year and a relevant PhD degree substitutes up to three years of four years of work experience
- Sound knowledge in regulatory requirements, e. g. MDD (93/42/EEC) and other related requirements
- Sound knowledge in product-, technology- quality- or other related standards
- Orientation towards the safety and performance of medical devices
- Correctness
- Ability to work in an intercultural environment
- Ability to plan and organize work
- Proficiency in MS Office
- Common sense and pragmatism
- Auditor according to ISO 13485 and MDD / AIMDD and CMDCAS and JGMP (a plus)
- Sound knowledge in product-, technology- quality- or other related standards
- Willingness to travel (domestic and international)


MHS Active Program Manager Home Office Massachusetts United States Peabody/ New Brighton (MN) Massachusetts United States

Keywords: TUV SUD America, Peabody , Product Expert, Other , Peabody, Massachusetts

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