Senior Director, Quality Assurance & Regulatory Strategy

Moximed; Fremont (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Disability Insurance

401K

Paid time off plus holidays

Flexible work schedules

Job summary

A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate will manage compliance with FDA regulations and direct quality initiatives. Candidates with experience in orthopedic medical devices will be preferred. The organization values diversity and offers competitive compensation and benefits.

Qualifications

• 15+ years of experience in medical device quality assurance and/or regulatory affairs.
• Strong understanding of FDA and international regulatory requirements.
• Ability to manage teams and complex projects.

Responsibilities

• Lead the Quality Assurance team and manage quality systems.
• Direct regulatory filings and oversee compliance activities.
• Ensure ongoing quality improvement initiatives are met.

Skills

Leadership

Regulatory knowledge

Quality management

Interpersonal skills

Analytical skills

Education

Bachelor’s or advanced degree in Life Sciences or engineering

Tools

ISO13485

FDA regulations

Job description

A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate will manage compliance with FDA regulations and direct quality initiatives. Candidates with experience in orthopedic medical devices will be preferred. The organization values diversity and offers competitive compensation and benefits.