Principal Regulatory Affairs Specialist

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

I'm hiring a Principal Regulatory Affairs Specialist for an innovative, publicly traded medical device company developing next-generation technologies for minimally invasive procedures.

With an expanding product portfolio and several critical regulatory milestones approaching, this is a high-impact opportunity to take ownership of global regulatory submissions, drive European market approvals and work directly with senior leadership within a growing organisation.

The Opportunity

• 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.

What I'm Looking For

• 8-10+ years of Regulatory Affairs experience within the medical device industry.
• Proven success achieving CE Marking under EU MDR 2017/745, ideally 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.
• An independent, collaborative regulatory professional comfortable taking ownership in a fast‑paced, growing organisation.

Why Consider This Opportunity?

• High‑impact position with genuine ownership of upcoming European regulatory submissions.
• Opportunity to support innovative medical technologies progressing towards commercialisation.
• Direct exposure to senior leadership within a growing, publicly traded organisation.
• Competitive compensation, 10% annual bonus, equity and comprehensive benefits.