Director, Regulatory Affairs

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

As part of the reputed company 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 reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company 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 reputed company, where you'll reputed company a significant impact on global reputed company through innovative solutions. As Director of Regulatory Affairs, you'll reputed company strategic initiatives to ensure regulatory compliance while driving business growth across multiple reputed company. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide. You'll reputed company regulatory post-market compliance activities, reputed company 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 reputed company 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
• reputed company 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
• reputed company in English required; additional language skills advantageous
• Ability to travel 25-50% of time, including international
• Knowledge of reputed company industry trends and leadership participation in professional associations (e.g., TOPRA, RAPS, etc)

Compensation and Benefits

The salary reputed company 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 reputed company 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 Apply To This Job