Senior Regulatory Affairs Specialist

Responsibilities :

• Evaluate medical device and SaMD regulations and develop global regulatory strategies to bring products to market.
• Review and approve design control documentation, risk management files, and product labeling in accordance with FDA, EU MDR, and other international regulations Author and manage FDA submissions, including:

• Q-Submission (Q-Sub) requests
• Traditional and Special 510(k) submissions
• Regulatory filings for Software as a Medical Device (SaMD)

• Prepare and maintain EU Technical Documentation and support CE Marking activities under EU MDD/MDR.
• Independently assess product changes for regulatory impact (US FDA, CE Mark, and US markets) and prepare resulting regulatory notifications
• Communicate regulatory changes to global regions and support preparation of global submissions and notifications.
• Stay current with new and evolving regulations, including emerging requirements such as the EU AI Act, and communicate impacts to project teams.
• Maintain regulatory databases, systems, and submission trackers
• Support regulatory inspections, audits, CAPAs, and other compliance-related activities.
• Review advertising and promotional materials for regulatory compliance.
• Participate in and lead regulatory training initiatives
• Mentor and support the development of junior regulatory team members.
• Comprehensive understanding of global medical device regulations, with strong focus on US FDA and EU MDR.

Requirements:

• 5+ years of Regulatory Affairs experience in a regulated industry, preferably medical devices and SaMD.
• Bachelor’s degree (MBA a plus)
• Strong experience with US FDA Class I and II medical devices.
• Proven end-to-end experience owning regulatory submissions and approvals, including responding to regulatory deficiencies.
• Hands-on experience working with:

• US FDA
• EU Notified Bodies
• Other international regulatory agencies
• ISO 13485 Auditor Certification (external auditor certification).
• Strong understanding of SaMD regulations and digital health requirements.
• Familiarity with AI Acts and software-driven regulatory considerations.