Medical Device Compliance Engineer / Auditor - Regulatory

TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has immediate openings throughout the United States (Peabody, Massachusetts, New Brighton, Minnesota and San Diego, CA) for

  Medical Device Auditors / Regulatory Compliance Engineers


 Your role and responsibilities include assessment of medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management. Responsibilities:

· Perform audits of clients per European Medical Device Directives (AIMD, MDD, IVDD) and International quality system standards (e.g. ISO 9000, ISO 13485) as well as internal MHS division and TÜV SÜD America criteria including all related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission at the certification committee.

· Act as Test engineer and Technical Certifier for TÜV SÜD America; inspect and test products for conformity with international regulations, with the end result being the certificate of conformance for the client.

·Prepare reports and documentation for certification of customer products to the appropriate standards.  Perform Constructional Review, Testing, and Preliminary Evaluations activities

· Provide project management for NAFTA-based customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.

· Interact with sales and marketing to initiate business, conduct informational meetings with prospective clients, follow-up on leads, and generate quotes. Overall, provide the client information and access to the full-range of services and products of TÜV SÜD America Inc.

· 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.

· Keep abreast of present and pending MHS tools, regulatory requirements, standards and TÜV SÜD America Engineering service capabilities through internal training sessions, external seminars, and reading of technical articles.
Requirements:

· The ideal candidate will have a BS or MS Degree in a science related field (electrical engineering, mechanical engineering, biotechnology, Bioengineering, biology, chemistry, microbiology,, etc.)

· Significant industrial medical device experience e.g. as Product Designer / Product Development Scientist / Project Manager / Microbiologist / Sterilization Specialist / Engineer / Regulatory Affairs / Quality Assurance.

· Minimum of 5 years experience in an industrial medical device environment, ideally 2 years of them in Quality.

· Direct auditing experience (Medical Device Directives AIMD, MDD, CMDR, JGMP, IVD, ISO 13485:2003) and Lead Auditor Certification is beneficial. Medical Devices Directive and Active Implantable Medical Devices Directive experience.

· German or Spanish language a plus.

· Extensive Local and domestic travel and occasional international travel is required.



We offer excellent medical and dental health plans, and participation in the company 401(k) retirement savings plan. We will provide a path to become an ISO13485 Medical Device Lead Auditor, Notified Body Auditor, FDA 3rd party 510K reviewer.






Headquartered in Peabody, MA, TÜV SÜD America Inc., a $100 million subsidiary, provides management system certification services to ISO 9001, ISO 14001, AS9100, AS9120, ISO 13485, TL 9000, Safe Quality Food (SQF), ISO 22000 and more. TÜV is a leading EU Notified Body for the Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Directives. Testing services include CE Marking assistance, Mechanical/Electrical Product Safety, Electromagnetic Compatibility (EMC), Environmental Testing, NRTL and SCC certification, Restricted Substance Services, International Compliance Services and more. Globally, TÜV has issued over 190,000 product and 30,000 quality management system certifications. For more information, visit www.TUVamerica com. TÜV SÜD America offers a competitive compensation package that includes health insurance and participation in the company 401(k) retirement savings plan.

TÜV SÜD is one of the leading providers of approval services for medical devices. Represented at 44 locations in major economic centers, the medical Health and Services experts support over 1,000 customers in all issues related to the certification and testing of medical devices and in-vitro diagnostics for target markets in Europe, Asia, America and Australia. With a 30 percent market share, TÜV SÜD Product Service is the world’s leading provider of approval services for high-risk products.






Thank you for your interest in TÜV SÜD America!  For direct contact you may email at careers@tuvam.com