Director, Regulatory Affairs

Thermo Fisher Scientific

Director of Regulatory Affairs leading compliance and strategy at Thermo Fisher Scientific. Overseeing regulatory activities and shaping strategies for global healthcare innovations.

Posted 5/20/2026full-timeRemote • California, Illinois, North Carolina, Virginia • 🇺🇸 United StatesLead💰 $175,000 - $219,000 per yearWebsite

About the role

Key responsibilities & impact

Lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions
Develop and implement regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide
Oversee regulatory post-market compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions
Collaborate with cross-functional teams to shape regulatory strategy for product development, manufacturing, and commercialization
Influence global regulatory policy and drive innovation in regulatory approaches

Requirements

What you’ll need

Advanced Degree plus 8 years of experience, or Bachelor's Degree plus 10 years of experience in IVD/medical device regulatory affairs
Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
Comprehensive knowledge of global regulatory requirements, particularly FDA as well as global health authorities ( e.g. Japan PMDA, China NMPA, Brazil ANVISA, Health Canada etc.)
Successful track record of regulatory submissions and agency interactions
Experienced in direct, professional, regulatory interactions with customers, pharma, and OEM business partners
Leadership experience managing and mentoring multi-site, multi-national teams
Experience in regulatory strategy development and implementation
Demonstrated expertise in regulatory compliance and quality management systems
Advanced project management and organizational skills
Excellent verbal and written communication abilities
Effective negotiation and influencing skills
Ability to work effectively in a matrix organization
Business acumen and strategic thinking capabilities
Proficiency in standard office technology and regulatory systems
Fluency in English required; additional language skills advantageous
Ability to travel 25-50% of time, including international
Knowledge of current industry trends and leadership participation in professional associations (e.g., TOPRA, RAPS, etc)

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory complianceregulatory strategy developmentregulatory submissionsquality management systemsproject managementglobal regulatory requirementsFDA regulationspost-market complianceproduct commercializationregulatory interactions

Soft Skills

leadershipmentoringcommunicationnegotiationinfluencingorganizational skillsbusiness acumenstrategic thinkingcollaborationmatrix organization effectiveness