The World Leader In Serving Science
Director, Regulatory Affairs
Location
Virginia + 5 moreAll locations: Virginia | Massachusetts | Illinois | North Carolina | France | Finland
Posted
7 days ago
Salary
$175K - $219K / year
Seniority
Lead
No structured requirement data.
Job Description
Director, Regulatory Affairs
Thermo Fisher Scientific
Title: Director, Regulatory Affairs - Remote, Virginia, United States of America - Remote, France - Finland - Remote, Massachusetts, United States of America - Remote, Illinois, United States of America - Remote, North Carolina, United States of America - Remote, California, United States of America Full time 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
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