Director, Regulatory Affairs

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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.

DESCRIPTION

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

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) Compensation and Benefits The salary range estimated for this position based in Virginia is $175,000.00-$219,000.00. 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 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 complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.