Sr Manager, Regulatory Affairs

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.
Position Summary
Lead the global Regulatory Affairs (RA) team and provide organizational guidance and support to Thermo Fisher Scientific’s Laboratory Plastic Essential (LPE) business within the Laboratory Product Group (LPG). The main activities revolve around developing and maintaining the team’s capabilities for regulatory activities that support the LPE business portfolio throughout its product life cycle. Delivering strategic and tactical regulatory support to the business and project teams is a crucial aspect in assisting the Company in achieving its business goals. The incumbent will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs, the incumbent will serve as a member of the LPE leadership team.
Responsibilities
Responsible for developing strategies, systems, and processes to ensure a high level of regulatory compliance within LPE.
Responsible for leading and developing the global RA team supporting LPE.
Responsible for reviewing and providing guidance to the business related to regulatory requirements for LPE product development and registrations (e.g., ISO, FDA, IVDD/IVDR, MDD/MDR), as well as product safety and regulatory compliance.
Overseeing the regulatory submission to regulatory agencies, notified bodies and certification bodies and ensure timely approval.
Oversight of product compliance test (conditions, EMC, safety etc.) planning and coordination. Responsible for signing EC Declaration of Conformities for regulated and electronics products and Quality Certificates when applicable.
Responsible for understanding and interpreting changes in regulatory standards and/or requirements for the business from different countries and regions.
Work closely with Quality partners to ensure Post Market Surveillance and Vigilance reporting is completed.
Supports internal and external QMS audits and providing support for Management Reviews as needed.

Minimum Requirements/Qualifications

• Bachelor’s degree in engineering or science discipline, advanced degree is plus
• 8+ years of work experience in regulatory and compliance field, familiar with working with regulatory authorities globally
• Five years of people management experience
• Strong communication skills
• Attention to details
• Comfortable working in a matrixed environment

Please refer the Job description for details