Catalyst MedTech Search · 1 day ago
Sr Regulatory Affairs Specialist
Los Angeles, CA, US
Full-time
Onsite
Senior Level
7+ years expCatalyst MedTech Search is looking for a Senior Regulatory Affairs Specialist to support commercialized medical devices and active FDA submissions. The role involves owning regulatory strategy, preparing FDA submissions, and executing post-market compliance activities.
Staffing & Recruiting
Responsibilities
Own and support regulatory strategy for marketed medical devices across the product lifecycle
Assess regulatory impact of design, manufacturing, labeling, process, and supplier changes
Support change control, design change assessments, CAPAs, and investigations
Prepare and support FDA regulatory submissions (primary near-term focus)
Support EU MDR Technical Documentation updates and international filings
Execute post-market compliance activities, including:
FDA establishment registration, device listing, and GUDID
EU MDR / EUDAMED updates
Complaint assessment and vigilance reporting (FDA/EU)
Support regulatory aspects of field actions, recalls, and corrections/removals
Participate in and support FDA, Notified Body, and international audits
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
10+ years of medical device regulatory experience (7+ years considered)
Hands-on experience with FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971
Strong background supporting commercialized products and post-market changes
Prior ownership of successful FDA 510(k) and/or PMA submissions
Experience with Class II and/or Class III devices
Exposure to international regulatory markets (Canada, Australia, Asia-Pacific a plus)
Comfortable working in a startup or fast-paced environment
Company
Catalyst MedTech Search
Catalyst is a niche recruitment firm partnering with U.S.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase