Director, Regulatory Affairs
About The Position
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Join our Regulatory Affairs team at Thermo Fisher Scientific, where you'll make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide. You'll oversee regulatory post-market compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams, you'll shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance. This role offers the opportunity to influence global regulatory policy and drive innovation in our regulatory approaches.
Requirements
- Advanced Degree plus 8 years of experience, or Bachelor's Degree plus 10 years of experience in IVD/medical device regulatory affairs
- 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
- Ability to travel 25-50% of time, including international
Nice To Haves
- Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
- additional language skills advantageous
- Knowledge of current industry trends and leadership participation in professional associations (e.g., TOPRA, RAPS, etc)
Responsibilities
- Lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions.
- Develop and implement regulatory strategies.
- Mentor teams.
- Manage critical relationships with regulatory agencies worldwide.
- Oversee regulatory post-market compliance activities.
- Provide expert guidance on regulatory requirements.
- Ensure successful product submissions across various jurisdictions.
- Shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance.
- Influence global regulatory policy and drive innovation in our regulatory approaches.
Benefits
- 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
- short- and long-term disability in accordance with company policy
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
