Principal Global Regulatory Affairs Specialist

The role

The Principal Global Regulatory Affairs Specialist develops and implements global regulatory strategies for medical devices in general surgery, cardiac surgery, and dermatology. This person provides strategic guidance to cross-functional teams and manages interactions with global health authorities.

What you will do

• Implement global regulatory strategies for surgery and dermatology products.
• Manage international regulatory affairs including Technical Files and Design Dossiers for CE Marking.
• Support FDA regulatory with creation and submission of 510ks, Pre-subs, IDEs, and PMAs.
• Oversee product registration submission and progress reports.
• Interact with regulatory agencies to expedite submissions.
• Monitor regulatory outcomes and provide input to senior management.
• Collaborate with clinical operations for regulatory submissions.
• Perform adverse event reporting and assessments.
• Establish procedures for MDR/CE Marking processes.
• Serve as regulatory liaison throughout the product development lifecycle.

Required qualifications

• Bachelor’s degree in Engineering, technical related discipline, other life science related discipline or equivalent experience.
• 10+ years of experience in Global Regulatory Affairs in the medical device or biotechnology industries, or 8+ years of experience with a Master’s degree.
• Experience creating PMA submission and CE Marking under MDR required.
• Experience with Notified Body, Authorized Representative, Competent Authority and regulatory intelligence activities.
• Knowledge of current EU regulations and Notified Body conformity assessment.
• Experience with health authority meeting preparation.
• Experience with Class III devices.
• Solid understanding of EU MDR 2017/745, ISO 13485: 2016 and FDA QSMR regulations.
• Hands-on experience preparing, managing and submitting major regulatory submissions.
• Proficient knowledge and skill in Microsoft Office Suite applications.
• Ability to travel up to 10% of the time.
• Ability to lift 10-15 pounds.

Nice to have

• Regulatory experience in general/plastics surgery, cardiology, and/or dermatology (aesthetics)

Benefits

• A variety of health insurance plans
• Supplemental insurance options
• 401k retirement savings plan
• Stock options awards
• Employee Stock Purchase Plan (ESPP)
• Paid time off
• Paid holidays
• Flexible work schedule
• Wellness program
• Onsite gym
• Mindfulness classes

Before you apply

• Candidates must reside in the San Francisco Bay Area
• No relocation offered

About the company

Pulse Biosciences is a bioelectric medicine company that develops CellFX nsPFA technology for surgical treatments. The company aims to improve the quality of life for patients through nano-pulse technology.