A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
Regulatory Affairs Specialist II Thermo Fisher Scientific - 3.4 Fremont, CA Job Details Full-time $72,000 - $96,000 a year 16 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 Content creation for technical audiences Technical documentation GMP Compliance documentation Regulatory submission editing and review Biomedical regulatory compliance Managing projects Productivity software Technical writing experience within technology Cross-functional collaboration Technical Proficiency Information management
ISO 13485
Cross-functional communication Product lifecycle management 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 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.
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 Fluency in English required; additional languages beneficial 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 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: https://jobs.thermofisher.com/global/en/total-rewards
