The Medical Healthcare Services Division of TÜV America Inc., a global specialist for product
safety testing and certification, has an immediate opening for a Product Manager located at
our Danvers Massachusetts location.
The Product Manager will lead and motivate a team of 10 employees in the east region.
TÜV America Inc., a subsidiary of TÜV Süddeutschland, offers a full suite of services to help
our clients meet regulatory and market access requirements of the global marketplace. Whether
our client’s business is concerned with export and acceptance within Europe, Japan, the US or
more, they will find the answers and solutions available through TÜV America’s medical
experts. Services offered include:
*** The leading European Union Notified Body for the:
* In Vitro Diagnostic Directive (IVDD)
* Medical Devices Directive (MDD)
* Active Implantable Medical Devices Directive (AIMDD)
*** The leading FDA 510(k) Third Party Reviewer of Eligible Class 1 and Class 11 Medical
*** Electromagnetic Compatibility Testing and Certification of Electro-medical Devices.
*** Quality Management Systems Registrar (ISO 9000, ISO 13485, ISO 14000 etc.)
*** Japanese In Country Caretaker service.
A B.Sc. or M.Sc. in Medical Technology, Biomedical Engineering or Electronics related fields.
Minimum of 7 years experience in regulatory affairs management for Medical Devices. A thorough
understanding of European Medical Devices Directives, Conformity Assessment procedures, as well
as the FDA regulatory environment, required. RAPS certification preferred, also ISO 9000/RAB
Lead Assessor qualification. The candidate should have solid experience in the implementation
of the above regulations in a corporate environment.
TÜV America offers excellent health benefits and participation in the company 401(k)
retirement savings plan. Please send résumé and salary requirements to Gillian Stack, Human
Resource Manager, TÜV America Inc, 5 Cherry Hill Drive, Danvers MA 01923. Fax (978) 777 8441
or email firstname.lastname@example.org