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Senior Manager of Regulatory Compliance
2 months ago
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Job Overview
Thermo Fisher Scientific Inc. stands as the premier entity in advancing scientific endeavors, boasting annual revenues surpassing $35 billion. Our mission is to empower our clients in creating a healthier, cleaner, and safer world.
Whether our clients are propelling life sciences research, tackling complex analytical challenges, enhancing patient diagnostics and therapies, or boosting productivity in their laboratories, we are dedicated to providing unwavering support.
Our diverse team of over 130,000 professionals delivers an exceptional blend of innovative technologies, convenient purchasing options, and pharmaceutical services through our industry-leading brands.
Position Summary
Oversee the global Regulatory Affairs (RA) team and furnish organizational guidance and support to Thermo Fisher Scientific's Laboratory Plastic Essential (LPE) division within the Laboratory Product Group (LPG).
The primary focus is on cultivating and sustaining the team's capabilities for regulatory initiatives that underpin the LPE business portfolio throughout its product lifecycle.
Providing strategic and tactical regulatory support to the business and project teams is vital in aiding the Company in reaching its business objectives.
The incumbent will also be tasked with fostering talent development within the team.Reporting to the Senior Director of Regulatory Affairs, the incumbent will be an integral member of the LPE leadership team.
Key Responsibilities• Formulate strategies, systems, and processes to guarantee a high level of regulatory compliance within LPE.
• Lead and nurture the global RA team supporting LPE.
• Review and offer guidance to the business regarding regulatory requirements for LPE product development and registrations (e.g., ISO, FDA, IVDD/IVDR, MDD/MDR), alongside product safety and regulatory compliance.
• Oversee product compliance testing (conditions, EMC, safety, etc.) planning and coordination. Responsible for signing EC Declaration of Conformities for regulated and electronic products and Quality Certificates when applicable.
• Interpret and comprehend changes in regulatory standards and/or requirements for the business across various countries and regions.
• Collaborate closely with Quality partners to ensure Post Market Surveillance and Vigilance reporting is executed.
• Support internal and external QMS audits and provide assistance for Management Reviews as necessary.
Minimum Requirements/Qualifications
• Bachelor's degree in engineering or a science discipline; advanced degree is advantageous.
• 8+ years of experience in the regulatory and compliance sector, with familiarity in engaging with regulatory authorities globally.
• Five years of experience in people management.
• Excellent communication skills.
• Strong attention to detail.
• Comfortable operating in a matrixed environment.
Benefits:
We provide competitive remuneration, an annual incentive plan bonus scheme, healthcare, a company pension, and a variety of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, along with outstanding career and development opportunities.
Compensation and Benefits
The estimated salary range for this position is $118,100.00–$177,200.00.
This role may also qualify for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
• A selection of national medical and dental plans, along with a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of 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) allows eligible colleagues to purchase company stock at a discount.
For further details on our benefits, please visit:
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
