Regulatory Affairs Specialist II
Thermo Fisher Scientific, Fremont, CA, Onsite
Regulatory Affairs ComplianceBachelor RequiredMid Level
About the role
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