Senior Regulatory Affairs Specialist

Job overview

The Senior Regulatory Affairs Specialist role is 100% onsite in Westlake Village, CA. Compensation is $100,000–$130,000 per year. Caldera Medical’s mission is to improve the quality of life for women through innovative surgical solutions and expanded access to care.

What you'll do

• Develop regulatory strategies and prepare, review, submit, and maintain medical-device regulatory documentation and licenses. Coordinate with R&D, Quality, Clinical, and Marketing
• communicate with regulatory agencies
• support audits, post-market surveillance, labeling and registration compliance, product lifecycle planning, and clinical studies
• and guide junior team members as needed.

What we're looking for

Skills & competencies

senior regulatory affairs specialist

medical devices

regulatory submissions

global regulations

westlake village ca

caldera medical

$100k–$130k

eu mdr

mdsap

women’s health

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision coverage
• 401(k) with 4% match after 90 days
• life and AD&D coverage
• unlimited vacation
• six weeks of paid maternity leave
• and 10 paid holidays.

Why this role

The posting requires five to seven years of medical-device regulatory affairs experience and states that sponsorship is unavailable; additional hours or travel may be needed for time-sensitive projects.

About the employer

Caldera Medical is hiring for this role. Industry: Offices of All Other Miscellaneous Health Practitioners. Sector: 62.