Senior Regulatory Affairs Specialist - Pleasanton, CA
$145,000–$160,000 year
HybridPleasanton, California, United States
Job Summary
Prepare, author, and manage U.S. and international regulatory filings including 510(k)s and letters to file, ensuring timely, high-quality deliverables for higher-risk devices. Serve as a key regulatory representative on cross-functional teams to support communications with the FDA and global bodies, including preparation for audits and inspections. Provide regulatory input into product development, design enhancements, and labeling decisions to ensure compliance is built into the process. Support regulatory compliance activities such as CAPAs, NCMRs, and complaints while monitoring proposed regulatory changes from the FDA and communicating updates to stakeholders. Maintain visibility into evolving global requirements to support domestic and international registration and listing activities. This individual contributor role requires a Master's degree with five years of relevant regulatory affairs experience in the medical device industry. The position offers a base salary of $145,000 - $160,000 with stock options and benefits including 401(k) and healthcare. Located in Pleasanton, CA, the role involves up to 8 hours of in-person or hybrid work daily with 5% travel.
Required Qualifications
- Master's degree with a minimum of 5 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 8 years of directly relevant regulatory affairs experience, in the medical device, pharmaceutical, biotechnology, or in vitro diagnostics (IVD) industry, including experience with Class II or Class III electromechanical medical devices
- Prior experience with the FDA and/or other regulatory agencies
- Proven success owning regulatory submissions such as 510(k)s and letters to file
- Supporting regulatory strategy through product development lifecycles
- Experience providing regulatory guidance in areas such as biocompatibility, packaging, sterilization, labeling, and review of product claims and promotional content
- Strong understanding of U.S. regulatory requirements
- U.S. and/or European/International regulations and standards knowledge
- Demonstrated ability to work effectively with cross-functional teams
- Strong technical writing, organizational, and communication skills
- Proven analytical capabilities
- Solid understanding of manufacturing, change control, and awareness of regulatory industry trends
- Experience with medical device eQMS
- Effective communicator and relationship-builder with cross-functional stakeholders and external regulators
- Bachelor's degree in Life Sciences, Engineering, or related field
- Legal authorization to work in the United States
- Compliance with relevant county, state, and Federal rules regarding vaccinations
- Must be able to sit for up to 8 hours/day
- Travel: 5% travel may be required
- Location: Pleasanton office (in-person or hybrid)
Desired Qualifications
- Familiarity with EU MDR and other international regulations
- Advanced degree
- RAC certification
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