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Director, Regulatory Affairs & Quality Assurance - medical device
Director, Regulatory Affairs & Quality Assurance - medical deviceInnoTech Staffing • Burlington, MA, US
Director, Regulatory Affairs & Quality Assurance - medical device

Director, Regulatory Affairs & Quality Assurance - medical device

InnoTech Staffing • Burlington, MA, US
[job_card.variable_days_ago]
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  • [job_card.full_time]
  • [job_card.permanent]
[job_card.job_description]

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

  • Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
  • 8+ years of experience in FDA and EU medical device Regulatory Affairs and Quality Assurance, with demonstrated expertise in global regulatory requirements and quality system standards.
  • Minimum of 5 years of medical device quality assurance experience with strong working knowledge of ISO 13485 and FDA QSR.
  • Experience in preparing and managing regulatory submissions (e.g., 510(k), EU MDR) and supporting regulatory audits / inspections.
  • Excellent organizational, leadership, interpersonal, and communication skills.
  • Demonstrated success in a hands-on, fast-paced, cross-functional medical device environment.

    • Specialized Skills / Other Requirements

  • Strong understanding of risk / benefit analysis, product safety principles, and regulatory science applicable to interventional medical devices.
  • Proven ability to effectively manage multiple complex projects and enforce timelines in a growing organization.
  • Strong technical writing skills and the ability to create clear, compliant regulatory and quality documentation.
  • Ability to collaborate across departments including R&D, Manufacturing, Operations, Clinical, and Marketing.
  • 10% to 25% travel may be required for audits, regulatory meetings, and supplier visits.
  • Self-starter with excellent attention to detail and the ability to follow through on commitments.

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

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    Director Quality Assurance • Burlington, MA, US

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