Regulatory Affairs Specialist III

Regulatory Affairs Specialist III Thermo Fisher Scientific - 3.4 Fremont, CA Job Details Full-time $90,900 - $121,200 a year 15 hours ago Benefits Commuter assistance Paid parental leave Caregiver leave Employee stock purchase plan Paid holidays Disability insurance Health insurance Dental insurance 401(k) Tuition reimbursement Paid time off Parental leave Employee assistance program Vision insurance Life insurance Qualifications FDA submissions ISO standards GMP Project management lifecycle Quality risk management Biomedical regulatory compliance Regulatory submissions Productivity software Regulatory compliance analysis Technical Proficiency Cross-functional communication Full Job Description 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 Thermo Fisher Scientific as a Regulatory Affairs Specialist III and contribute to ensuring compliance with global regulations while enabling our mission to make the world healthier, cleaner, and safer. You'll provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio. Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes.

Location:

Fremont, CA. Relocation assistance is NOT provided.

REQUIREMENTS

Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in regulatory affairs in the pharmaceutical, medical device, or diagnostics industry

Preferred Fields of Study:

life sciences, chemistry, engineering, pharmacy, or related scientific field Additional certifications like RAC (Regulatory Affairs Certification) advantageous Strong knowledge of global regulatory requirements, particularly FDA, EU MDR/IVDR, and other major markets' regulations Experience preparing and submitting regulatory filings (e.g., 510(k), CE marking, technical files) Demonstrated success in regulatory strategy development and implementation Expert understanding of quality systems (ISO 13485, GMP/QSR) and risk management principles Excellent project management skills with ability to manage multiple projects simultaneously Strong analytical and problem-solving capabilities Clear written and verbal communication skills Experience working effectively in cross-functional team environments Proficiency with regulatory submissions software and Microsoft Office suite Experience with change control and post-market surveillance activities Strong attention to detail and organizational skills Ability to interpret and apply complex regulatory requirements Customer-focused mindset with business acumen Available for occasional travel (10-20%) Effective interpersonal skills and ability to build consensus Experience supporting regulatory staff development preferred Must be legally authorized to work in the United States without sponsorship Must be able to pass a comprehensive background check, which includes a drug screening Compensation and Benefits The salary range estimated for this position based in California is $90,900.00-$121,200.00. 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