Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs youll 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.

Youll 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 youll 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 Bachelors 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 $175000.00$219000.00.

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: Experience:

Director

Job Tags

Full time, Temporary work, Work at office, Worldwide

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