Product Expert - Sterilization/Biocompatibility
- Posted: over a month ago
TÜV SÜD America Inc., a global leader in testing, inspection, and certification, has an immediate opening for a Product Expert - Sterilization/Biocompatibility, based in the United States in a remote position.
Your duties 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 a limited extent): Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDR, IVDR), 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 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 the 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 TÜV SÜD America service capabilities through internal training sessions, external seminars, and reading of scientific articles.
This position may be for you if:
- Minimum BSc degree in Biology, Microbiology, Chemistry, Biochemistry or equivalent
- Four years of work experience in Design Assurance, Regulatory Affairs, R&D, or Quality are preferred.
- Experience with Functional area of Sterilization: EO, Y/E-beam, Moist, Reprocessing, Chemical, Aseptic, Plasma, etc. and/or biocompatibility, drug, animal origin, resorbable or nanomaterial expertise.
- A relevant master’s degree substitutes one year of work experience, and a relevant Ph.D. 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
- Proficiency in MS Office
- Common sense and pragmatism
- Auditor according to ISO 13485 and MDR (a plus)
- Willingness to travel (domestic and international)
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: https://653988.extforms.netsuite.com/app/site/hosting/scriptlet.nl?script=70&deploy=1&compid=653988&h=6d5262aa43dfefb771d6&customerId=848956&token=27585917
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TÜV SÜD America
AddressSan Diego, CA
BusinessView all jobs at TÜV SÜD America