Regulatory Affairs Specialist III
$90,900–$121,200 year
On-siteFremont, California, United States
Job Summary
Develop and implement strategic regulatory strategies for product development, registration, and lifecycle management across a diverse portfolio. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to ensure global compliance with FDA, EU MDR/IVDR, and other major markets. Prepare and submit regulatory filings including 510(k), CE marking, and technical files while managing change control and post-market surveillance activities. Collaborate with cross-functional teams to enhance time-to-market while maintaining the highest standards of quality systems and risk management principles. Work within a standard Monday-to-Friday schedule in Fremont, CA, with occasional travel of 10-20%.
Required Qualifications
- 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
- 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
- Available for occasional travel (10-20%)
Desired Qualifications
- Experience supporting regulatory staff development preferred
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