Director Regulatory and Quality - RA/QA, 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!

The key to this role - looking for a knowledgeable "doer" with 10-15 years of experience that can not only lead and advise the company, but is in top of everything RA/QA. Someone willing to her their hands dirty and do whatever it takes to get the job done.

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.

90% of this role is internal and external audits, dealing with findings, CAPAs, updating procedures, returns, non conformities.

10% new submissions / regulatory approval in countries outside the US.

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.

· 10+ 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 10 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, bonus, medical/dental insurance, 401(k), and professional development opportunities.