Director of Regulatory Affairs and Quality Assurance

Job overview

The Director of Regulatory Affairs and Quality Assurance role is onsite in Eden Prairie, MN, with compensation not specified. The position reports to the VP of Technology and works across RxFunction’s critical functions on medical device initiatives. The director leads regulatory strategy and quality systems so products can meet applicable requirements, obtain market approvals, and maintain quality through development, production, and post-production activities.

What you'll do

• Direct the RA/QA department
• develop and implement global regulatory strategy
• identify applicable regulations and standards
• oversee regulatory submissions and supporting documentation
• implement and maintain the quality management system
• oversee product quality and risk management
• make product quality hold and release decisions
• serve as Quality Management Representative
• lead management reviews and chair the Cybersecurity Panel
• travel up to 20%.

What we're looking for

Skills & competencies

director

regulatory affairs

quality assurance

eden prairie mn

rxfunction

medical devices

fda submissions

quality management system

iso 13485

21 cfr part 820

leadership

travel up to 20%

Work arrangement

• Weekend coverage required

Why this role

Requires a related science or engineering bachelor’s degree, 15+ years of medical-device regulatory affairs and quality assurance experience, and 5+ years of supervisory experience.

About the employer

RxFunction is hiring for this role. Industry: Professional and Management Development Training. Sector: 61.