Regulatory Affairs Manager-US
Posted Updated
Description
Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.
Key Responsibilities
- Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products
- Develop and execute regulatory strategies supporting product development and commercialization
- Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance
- Interpret FDA guidance related to medical device software and digital health technologies
- Partner with global regulatory teams to support international regulatory initiatives
Requirements
- 5–10+ years of regulatory affairs experience in medical devices or healthcare software
- Proven experience with FDA 510(k) submissions, ideally for software-based medical devices
- Strong knowledge of SaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304)
- Experience working within a multinational organization
- Strong cross-functional collaboration and communication skills
Skills
As published by workable · 3 questions · 3 written answers
First name, Last name, Email, Phone, Address, Resume, Experience, Cover letter
- How many submissions through the FDA 510(k) Clearance Process have you personally led or authored, and were any for software-based products? If you did not lead, were you an integral part of the team submission?
- Do you have regulatory experience with software based medical devices or products classified as Software as a Medical Device (SaMD)?
- Have you interacted directly with the U.S. Food and Drug Administration during a regulatory submission (e.g., pre-submissions, additional information requests, or deficiency responses)?