Global Regulatory Affairs Leader - Medical Devices

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Stock options

ESPP

Health insurance

401k

Onsite gym

Job summary

Pulse Biosciences, Inc. is seeking a Principal Global Regulatory Affairs Specialist in Hayward, CA. The role leads global regulatory strategies for general, cardiac, and dermatology medical devices, coordinating with cross-functional teams and regulatory authorities.

You will drive submissions, ensure compliance with EU MDR, ISO 13485, and FDA requirements, and oversee post-market activities while supporting product lifecycle from development to approval.

Qualifications

• 10+ years of Global Regulatory Affairs experience in medical devices/biotech.
• Experience with PMA submissions and CE Marking under MDR.
• Knowledge of EU MDR 2017/745, ISO 13485:2016 and FDA QSMR.
• Experience with Notified Bodies and regulatory intelligence.

Responsibilities

• Develop and implement global regulatory strategies for general surgery, cardiology and dermatology devices.
• Prepare, review, and submit regulatory documentation (510(k), PMAs, IDEs, etc.).
• Manage international submissions and lifecycle activities including post-market surveillance.
• Collaborate with clinical, QA, and regulatory partners to ensure compliant submissions.
• Liaise with health authorities and regulatory bodies to expedite approvals.

Skills

Regulatory affairs

FDA submissions

EU MDR

PMAs

MS Office

Education

Bachelor's in Engineering

Master's degree

Tools

MS Office

Job description

Pulse Biosciences, Inc. is seeking a Principal Global Regulatory Affairs Specialist in Hayward, CA. The role leads global regulatory strategies for general, cardiac, and dermatology medical devices, coordinating with cross-functional teams and regulatory authorities.

You will drive submissions, ensure compliance with EU MDR, ISO 13485, and FDA requirements, and oversee post-market activities while supporting product lifecycle from development to approval.