Regulatory Affairs Specialist II

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 our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and market access for our innovative diagnostic solutions. You'll work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management systems across global markets. This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.

Location: Fremont, CA.

Relocation assistance is NOT provided.

REQUIREMENTS:

• Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in IVD/medical device industry
• Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
• Additional regulatory affairs certifications beneficial
• Comprehensive knowledge of global regulatory requirements, particularly FDA, EU IVDR/MDR, and regional regulations
• Strong understanding of quality management systems (ISO 13485, GMP, MDSAP)
• Experience preparing and reviewing technical documentation and regulatory submissions
• Expertise in product lifecycle management and change control processes
• Proven ability to interpret and apply regulatory requirements to product development and maintenance
• Excellent project management and organizational skills
• Strong analytical and problem-solving capabilities
• Superior written and verbal communication skills
• Proficiency in Microsoft Office and regulatory information management systems
• Ability to work effectively in a matrix organization and cross-functional teams
• Detail-oriented with strong documentation skills
• Demonstrated ability to manage multiple priorities and meet deadlines
• Experience with post-market surveillance and vigilance reporting
• 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 screenin

Compensation and Benefits

The salary range estimated for this position based in California is $72,000.00–$96,000.00.

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: