Regulatory Affairs Specialist III
About The Position
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
- 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
- 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
Nice To Haves
- Preferred Fields of Study: life sciences, chemistry, engineering, pharmacy, or related scientific field
- Additional certifications like RAC (Regulatory Affairs Certification) advantageous
Responsibilities
- 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.
- Support regulatory staff development.
- Participate in the job application or interview process.
- Perform essential job functions.
- Receive other benefits and privileges of employment.
Benefits
- 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
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
