AI summary
Evaluate and develop global regulatory strategies for medical devices and software as a medical device (SaMD), manage regulatory submissions including FDA and EU notifications, and mentor junior team members.
Eligible from: Unclear
Job Description
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.
About the job
- Posted on
- Sep 11, 2026
- Job type
- Full-time
- Location
- BangaloreOn-site
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