Global RA/QA Director, MedTech Compliance & Quality

Page Mechanical Group, Inc.; Eden Prairie (MN); On-site; USD 150,000 - 230,000; Full time

Job summary

Page Mechanical Group, Inc. seeks a Director of Regulatory Affairs and Quality Assurance to lead global regulatory strategies for RxFunction medical devices and manage FDA interactions.

The role ensures the regulatory program and QMS are effective across the organization, reporting to the VP of Technology. Responsibilities include building regulatory strategies, ensuring compliant submissions, maintaining documentation, and guiding product quality from development through post-production.

Qualifications

• Bachelor's degree in a related science or engineering discipline.
• 15+ years in Regulatory Affairs and Quality Assurance in medical devices, with 5+ years in supervision.
• Extensive knowledge of global regulatory requirements and market pathways for medical devices.
• Demonstrated understanding of ISO13485, 21CFR Part 820, and other FDA regulations.
• Experience in Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, and Regulatory Reporting to Authorities.
• Proven track record of positive interactions with FDA and other authorities for inspections and market approvals.
• Strong leadership, verbal and written communication, and organizational skills.
• Ability to travel up to 20% by car or plane.

Responsibilities

• Directs and oversees the RA/QA department.
• Provid es leadership, supervision, and development opportunities for direct reports.
• Verifies performance and makes fair performance decisions.
• Prepares annual department budget in coordination with Finance.
• Develops global regulatory strategy with key stakeholders and implements it.
• Identifies applicable regulations, standards, and guidance documents.
• Ensures compliant, complete regulatory submissions to FDA and international authorities.
• Maintains proper approval and documentation for submissions, when required.
• Implements and maintains an effective QMS with required documentation.
• Ensures product quality throughout development, transfer, production, and post-production activities.
• Makes final decisions on product quality holds and releases.
• Applies risk management throughout product realization.
• Develops, with stakeholders, the global regulatory strategy for RxFunction products and ensures implementation.
• Identifies applicable regulations, standards, and guidance documents.
• Ensures compliant submissions to FDA and international authorities.
• Keeps documentation approved and maintained for submissions.
• Implements and maintains an effective QMS.
• Ensures product quality from development to post-production.
• Serves as the Quality Management Representative.
• Ensures OMS processes are documented and maintained.
• Reports on OMS performance to leadership and drives improvement.
• Promotes awareness of OMS, regulatory and customer requirements.
• Chaired cybersecurity panel reviewing risk assessments, mitigations, and residual risk.

Skills

Leadership

Communication

Organizational skills

Travel up to 20%

Education

Bachelor's degree in related science/engineering

Job description

Page Mechanical Group, Inc. seeks a Director of Regulatory Affairs and Quality Assurance to lead global regulatory strategies for RxFunction medical devices and manage FDA interactions.

The role ensures the regulatory program and QMS are effective across the organization, reporting to the VP of Technology. Responsibilities include building regulatory strategies, ensuring compliant submissions, maintaining documentation, and guiding product quality from development through post-production.