Regulatory Affairs Lead – Medical Devices

imperativecare; Campbell (CA); On-site; USD 151,000 - 178,000; Full time

Benefits offered by this job

Stock options

401k plan

Health benefits

Generous PTO

Parental leave

Emotional health resources

Job summary

Imperative Care in Campbell, California is seeking a Lead Regulatory Affairs Specialist to drive regulatory strategies for medical devices across US and international markets. This on-site, full-time role partners with cross-functional teams to prepare submissions, manage timelines, and ensure compliance with FDA and global requirements.

You will lead multiple projects, review change controls, support registrations and listings, and mentor junior staff while advancing the company’s regulatory

Qualifications

• Bachelor’s degree in related field with 8+ years in healthcare/medical device regulatory roles.
• US and/or OUS regulatory submissions experience.
• Advanced degree or strong regulatory affairs experience preferred.
• RAC certification a plus.
• Experience with EU MDR, MDSAP is a plus.

Responsibilities

• Develop regulatory strategies for product changes and new product development.
• Advise cross-functional teams on regulatory affairs related to tests and Design Control.
• Prepare regulatory documents and filings (510(k), Notified Body submissions, etc.).
• Manage submissions timelines and respond to deficiency questions from regulators.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Project management

Regulatory operations

Technical writing

Education

Bachelor’s degree in related field

Advanced degree preferred

Job description

Imperative Care in Campbell, California is seeking a Lead Regulatory Affairs Specialist to drive regulatory strategies for medical devices across US and international markets. This on-site, full-time role partners with cross-functional teams to prepare submissions, manage timelines, and ensure compliance with FDA and global requirements.

You will lead multiple projects, review change controls, support registrations and listings, and mentor junior staff while advancing the company’s regulatory