Director of QA RA - Medical Device - Woburn, MA
Michael Page International Inc., Woburn, MA, United States
Lead RA/QA for a fastgrowing global medtech innovator
Own regulatory strategy and quality excellence for breakthrough therapies
About Our Client
Our client is a rapidly growing medical technology company developing advanced interventional solutions that improve patient outcomes worldwide. They operate at the intersection of engineering, clinical innovation, and highprecision manufacturing.
Job Description
Lead and develop the RA/QA organization, guiding global compliance and continuous improvement. Own the Quality Management System and ensure alignment with ISO 13485, FDA QSR, and evolving regulatory standards. Direct all internal and external audits, including GMP/QSR, notified bodies, and regulatory agency inspections. Manage regulatory submissions such as 510(k), EU MDR technical files, global registrations, and product listings. Oversee complaint handling, vigilance/MDR reporting, recalls, and import/export compliance. Drive internal and supplier audit programs to ensure high-quality materials, processes, and partnerships. Lead product and process validation programs (IQ/OQ/PQ) and ensure robust manufacturing compliance. Provide regulatory strategy and guidance across product development and lifecycle management. Serve as primary liaison with global regulators, partners, and notified bodies. Oversee daily RA/QA operations including CAPA, risk management (ISO 14971), document control, and quality metrics. Advise executive leadership on regulatory strategy, risk, and compliance status to support business decisions. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
Bachelor's degree in engineering or a scientific discipline; advanced degree preferred. 8+ years of RA/QA experience in medical devices with strong FDA and EU regulatory expertise. Minimum 5 years of quality assurance experience with deep knowledge of ISO 13485 and FDA QSR. Proven success preparing and managing regulatory submissions (510(k), EU MDR, global approvals). Strong organizational and leadership skills with experience in crossfunctional, fastpaced environments. Skilled technical communicator with experience supporting audits and inspections. What's on Offer
You'll lead RA/QA strategy for a company shaping the future of interventional medicine. High visibility role with direct influence on executive decisionmaking and global expansion. Opportunity to build and elevate a worldclass QMS and regulatory infrastructure. Work with cutting-edge technologies making a real impact on patient outcomes. Competitive compensation, strong benefits, and a culture focused on innovation and growth.
Contact
Taylor Rankin
Quote job ref
JN-032026-6982151
Our client is a rapidly growing medical technology company developing advanced interventional solutions that improve patient outcomes worldwide. They operate at the intersection of engineering, clinical innovation, and highprecision manufacturing.
Job Description
Lead and develop the RA/QA organization, guiding global compliance and continuous improvement. Own the Quality Management System and ensure alignment with ISO 13485, FDA QSR, and evolving regulatory standards. Direct all internal and external audits, including GMP/QSR, notified bodies, and regulatory agency inspections. Manage regulatory submissions such as 510(k), EU MDR technical files, global registrations, and product listings. Oversee complaint handling, vigilance/MDR reporting, recalls, and import/export compliance. Drive internal and supplier audit programs to ensure high-quality materials, processes, and partnerships. Lead product and process validation programs (IQ/OQ/PQ) and ensure robust manufacturing compliance. Provide regulatory strategy and guidance across product development and lifecycle management. Serve as primary liaison with global regulators, partners, and notified bodies. Oversee daily RA/QA operations including CAPA, risk management (ISO 14971), document control, and quality metrics. Advise executive leadership on regulatory strategy, risk, and compliance status to support business decisions. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
Bachelor's degree in engineering or a scientific discipline; advanced degree preferred. 8+ years of RA/QA experience in medical devices with strong FDA and EU regulatory expertise. Minimum 5 years of quality assurance experience with deep knowledge of ISO 13485 and FDA QSR. Proven success preparing and managing regulatory submissions (510(k), EU MDR, global approvals). Strong organizational and leadership skills with experience in crossfunctional, fastpaced environments. Skilled technical communicator with experience supporting audits and inspections. What's on Offer
You'll lead RA/QA strategy for a company shaping the future of interventional medicine. High visibility role with direct influence on executive decisionmaking and global expansion. Opportunity to build and elevate a worldclass QMS and regulatory infrastructure. Work with cutting-edge technologies making a real impact on patient outcomes. Competitive compensation, strong benefits, and a culture focused on innovation and growth.
Contact
Taylor Rankin
Quote job ref
JN-032026-6982151