Job Information
ThermoFisher Scientific Sr Manager, Regulatory Affairs in Rochester, New York
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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
Benefits:
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Compensation and Benefits
The salary range estimated for this position based in New York is $118,100.00–$177,200.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.