Director Regulatory and Quality - RA/QA, medical device

InnoTech Staffing•Burlington, MA

24d•Onsite

About The Position

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 on top of everything RA/QA. Someone willing to get 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.

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.
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.
Self-starter with excellent attention to detail and the ability to follow through on commitments.

Responsibilities

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.