Product Assessment Expert

Overview:

At TÜV SÜD 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, TÜV SÜD 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 medical devices and manufacturers’ quality management systems per regulatory 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.

The position is home-office based and requires approximately 20% travel activity.

Assessment of Technical Documentation:

Perform design and manufacturing documentation assessments of medical products to determine conformity with the European Medical Device Regulation, its general safety and performance requirements as well as relevant common specifications and standard requirements.

Example medical devices include stand-alone medical software and applications, IT systems, and active medical devices considering Functional Safety and Cybersecurity.

The expert has to determine whether the manufacturer has provided adequate proof that aspects related to the design and production units such as but not limited to constructional safety, lifetime reliability, biocompatibility, sterility, usability and clinical safety and performance are duly verified and validated, as well as evidence that the benefit applying the device and / or functions outweighs the residual risks.

Auditing:

Evaluation of medical device manufacturers Quality Management system to determine conformity with the European Medical Device Regulation and Medical Device Directives (MDR, 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 TÜV SÜD criteria including all related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission to the TÜV SÜD certification committees.

Project Management:

Provide project management for TÜV SÜD international customers. Project management potentially consists of cost calculation, coordinating multiple projects to meet due dates, status and information exchange within project teams, 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 TÜV SÜD service capabilities through internal training sessions, external seminars, and reading of scientific articles.

Knowledge and Skills:

- Sound knowledge in regulatory requirements, e. g. MDR, AIMDD (90/385/EEC), 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

- Ability to plan and organize work

- Interpersonal and communication skills

- Proficiency in MS Office

- Common sense and pragmatism

- Auditor according to ISO 13485 and MDR / MDD / AIMDD / MDSAP (a plus)

- Willingness to travel (domestic and international)

- Minimum Bachelor's Degree in biomedical, software, electrical, mechanical engineering or equivalent

- Four years work experience in design / product development / manufacturing / engineering of active implantable devices or other high-risk active devices

- 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

Equal Opportunity Employer – Disability and Veteran

TÜV SÜD 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: Labor Law 2024

Powered by JazzHR

KBZ7Y7ulEc