Director, Regulatory Affairs

Thermo Fisher Scientific Inc

MA

JOB DETAILS
SALARY
$175,000–$219,000 Per Year
SKILLS
Biology, Biotech and Pharmaceutical, Business Growth, Business Skills, Business Strategy, Cancer, Chemistry, Communication Skills, Corporate Policies, Cross-Functional, Customer Relations, Dental Insurance, English Language, FDA Requirements, Food Safety, Health Canada, Incentive Programs, Industry/Trade Analysis, International Health, Leadership, Life Insurance, Maintain Compliance, Manufacturing, Matrix Management, Medical Equipment, Mentoring, Microbiology, Negotiation Skills, OEM (Original Equipment Manufacturer), Organizational Skills, Pharmacy, Policy Implementation, Presentation/Verbal Skills, Product Development, Project/Program Management, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Relationship Management, Stock Purchase Plans, Strategic Planning, Vision Plan, Willing to Travel, Writing Skills
LOCATION
MA
POSTED
20 days ago

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

About the Company

T

Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html