Director, Regulatory Affairs & Quality Assurance - medical device

Job Description

Job Description

InnoTECH Staffing is looking to hire a fulltime permanent Director of Regulatory Affairs & Quality Assurance (RA / QA) for an exciting and growing medical device company in Burlington, MA. Candidate must be local and be able to go to office a few days a week.

Must be a US Citizen or Greencard Holder!

Our client is a medical device manufacturer committed to advancing cancer therapy through research, engineering, high-quality products, and exceptional physician support.

We are seeking a Director of RA / QA to lead all regulatory affairs and quality assurance activities for the company as they continue to expand their global presence and product portfolio.

Job Description

• Lead, manage, and develop the Regulatory Affairs and Quality Assurance functions to ensure organizational compliance with global medical device regulations and standards.
• Oversee the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory frameworks.
• Direct internal GMP / QSR audits and manage external audits from regulatory agencies, notified bodies, and key customers.
• Lead the preparation, submission, and maintenance of device regulatory submissions including EU MDR Technical Documentation, 510(k) applications, FDA listing / registration, and international market authorizations.
• Oversee and ensure compliance with complaint handling, medical device reporting (MDR / Vigilance), field corrections / recalls, and import / export regulatory requirements.
• Direct the creation, execution, and maintenance of internal and supplier quality audits; ensure suppliers meet regulatory and company quality expectations.
• Oversee product and process validation programs, including IQ / OQ / PQ activities, ensuring that products are consistently manufactured to specifications and compliant with regulatory expectations.
• Provide strategic regulatory input for new product development, design changes, and lifecycle management activities.
• Serve as the primary liaison with regulatory authorities, notified bodies, and external partners regarding regulatory and quality matters.
• Lead RA / QA daily operations including CAPA management, risk management activities (ISO 14971), document control, training, and quality metrics reporting.
• Advise executive leadership on regulatory strategy, quality trends, risk factors, and compliance status to support business objectives.

Education / Experience Requirements

Specialized Skills / Other Requirements

Full-time position with competitive compensation, medical / dental insurance, 401(k), and professional development opportunities.