Global RA/QA Director - Medical Devices Compliance & Quality

RxFunction, Inc.; Eden Prairie (MN); In loco; USD 170.000 - 210.000; Tempo pieno

Descrizione del lavoro

RxFunction, Inc. seeks a seasoned Director of Regulatory Affairs and Quality Assurance to lead our global regulatory strategy and QMS for emerging medical device initiatives.

You will interact with the FDA and Notified Bodies, develop regulatory strategies, and manage submissions while guiding QA across development, transfer to production, and post-market activities. The role requires 15+ years in RA/QA in medical devices, with deep ISO 13485 and 21 CFR Part 820 knowledge, and the ability to

Competenze

• Bachelor's degree in a related science or engineering discipline.
• 15+ years' experience in Regulatory Affairs and Quality Assurance within the medical device industry, with 5+ years of supervisory experience.
• Extensive knowledge of global regulatory requirements and market pathways for medical devices.
• Understanding of ISO 13485, 21 CFR Part 820 and other applicable FDA medical device regulations.
• Experience in Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, Complaint Handling, and Regulatory Reporting to Authorities.
• Proven track record of managing interactions with the FDA and other regulatory authorities regarding inspections/audits and market approvals.
• Strong leadership, verbal and written communication, and organizational skills.
• Ability to travel up to 20% by car or plane.

Mansioni

• Directs and oversees the RA/QA department.
• Secures market approvals for RxFunction products in target geographies.
• Develops global regulatory strategy and ensures its implementation.
• Ensures compliant regulatory submissions to FDA and international authorities.
• Implements and maintains an effective QMS including required documentation.
• Ensures product quality throughout development, transfer, production changes, and post-production.
• Acts as the Quality Management Representative and reports OMS performance to leadership.
• Chairs the Cybersecurity Panel and maintains ethics and confidentiality.

Conoscenze

Regulatory Affairs

Quality Assurance

Leadership

Communication

Strategic thinking

Project management

Risk management

Travel readiness

Cross-functional collaboration

Formazione

Bachelor's degree in science or engineering

MBA or advanced technical degree

Professional certifications (RAPS/ASQ)

Strumenti

eQMS software

MS Office (Word/Excel/PowerPoint)

Descrizione del lavoro

RxFunction, Inc. seeks a seasoned Director of Regulatory Affairs and Quality Assurance to lead our global regulatory strategy and QMS for emerging medical device initiatives.

You will interact with the FDA and Notified Bodies, develop regulatory strategies, and manage submissions while guiding QA across development, transfer to production, and post-market activities. The role requires 15+ years in RA/QA in medical devices, with deep ISO 13485 and 21 CFR Part 820 knowledge, and the ability to