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Cardiovascular Product Expert

Company: TUV SUD America
Location: Peabody
Posted on: November 4, 2019

Job Description:

Cardiovascular Product Expert 126332 Full time regular Professionals 3 - 5 years of experience Medical Devices & Healthcare T V S D America Inc., a global leader in testing, inspection and certification, has an immediate opening for a Cardiovascular Product Expert based in a home office.





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.
- Expertise: Keep abreast of present and evolving regulatory requirements, standards and T V S D America service capabilities through internal training sessions, external seminars, and reading of scientific articles.













At T V S D America, we are passionate about technology, people and the environment. Our commitment is to invest in our employees as well as to hire, develop, and engage the best talent to help us continue to build our team. We are dedicated to creating a work environment where all levels of employees are inspired to learn, grow, and be empowered to achieve both their professional as well as personal goals.


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.


It is T V S D s priority to stay true to our founding principle by creating a safer and more sustainable future. To protect people, property and the environment from technology-related risks now and in the future, our experts are driving the development of four strategic themes: consumer protection, digital transformation, sustainable development and urbanization. To learn more about T V S D, visit T V S D America today!


We offer a competitive compensation package that includes health insurance and participation in the company 401(k) retirement savings plan.


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: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


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






This job may be for you if have:


- Minimum BSc degree in biomedical, electrical, or mechanical engineering or equivalent
- Four years work experience in Candidates with experience in Design Assurance, combination of Regulatory Affairs with R&D, Quality are preferred.
- Experience with Functional area of Electrophysiology catheters such as Ablation catheters, structural heart including heart valves, transcatheter heart valves etc.
- A relevant master s degree substitutes one-year work experience, 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
- Precision and accuracy
- Ability to work in an intercultural environment
- Demonstrated experience in Project Management preferred.
- Proficiency in MS Office
- Common sense and pragmatism
- Auditor according to ISO 13485 and MDD / AIMDD and CMDCAS and JGMP (a plus)


Willingness to travel (domestic and international)


US-MHS-PA-APP Home Office United States

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

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