Senior Regulatory Affairs Lead: EU MDR & FDA Submissions

Metric Bio; California; On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

10% annual bonus

Equity

Comprehensive benefits

Job summary

Metric Bio is seeking a Principal Regulatory Affairs Specialist to own global regulatory submissions and drive EU market approvals for next‑generation medical devices. You will lead CE Marking efforts under EU MDR for Class III devices and collaborate with Notified Bodies and regulatory authorities.

You will also support US FDA activities, including PMA and IDE submissions, while partnering with R&D, Clinical and Quality teams to accelerate development and commercialization in a fast‑growing,

Qualifications

• 8–10+ years of Regulatory Affairs experience in the medical device industry.
• Proven CE Marking success under EU MDR 2017/745 for Class III devices.
• Strong hands-on experience preparing technical documentation, managing submissions and interacting with Notified Bodies.
• Knowledge of FDA regulatory pathways, including PMA submissions, is advantageous.

Responsibilities

• Lead EU MDR CE Marking submissions for complex Class III medical devices, taking ownership of technical documentation and regulatory strategy.
• Prepare and manage Technical Files, GSPRs and submissions, working directly with Notified Bodies and regulatory authorities.
• Support US FDA regulatory activities, including PMA, IDE and other regulatory submissions.
• Partner closely with R&D, Clinical and Quality teams to support product development, regulatory approvals and commercialisation.

Skills

Regulatory strategy

CE Marking (EU MDR)

Regulatory submissions

Documentation management

Notified Bodies liaison

FDA pathways knowledge

Cross-functional collaboration

Job description

Metric Bio is seeking a Principal Regulatory Affairs Specialist to own global regulatory submissions and drive EU market approvals for next‑generation medical devices. You will lead CE Marking efforts under EU MDR for Class III devices and collaborate with Notified Bodies and regulatory authorities.

You will also support US FDA activities, including PMA and IDE submissions, while partnering with R&D, Clinical and Quality teams to accelerate development and commercialization in a fast‑growing,