Head of Global Regulatory Affairs & Quality
Bedford, MA
Regulatory Affairs & Quality /
Full-time /
Hybrid
Lexington Medical is a medical device manufacturer in the Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market. Our business structure enables us to produce a unique range of devices and proprietary technology best suited for leading surgeons and their patients, while also quickly adapting to the everchanging market conditions.
Our recruiting philosophy is centered on attracting talented individuals committed to delivering innovation. Rooted in a talent dense culture that fosters continuous growth and achievement, both personal and organizationally, we've been organically scaling at a rapid pace and have aggressive hiring plans for the years ahead. By joining Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.
We are seeking a Head of Global Regulatory Affairs and Quality to develop and implement a regulatory affairs strategy, maintain compliance and continuously improve our quality management system (QMS), while leading a highly talented team.
Responsibilities:
- Provide strategic leadership to develop and implement regulatory strategies throughout the product lifecycle aligned to company goals and objectives.
- Preparation of amendments/supplements, new device applications, 510(k)s, technical documentation (EU MDR), and design dossiers
- Lead internal audit activities for MDSAP, EU MDR, and ISO 13485 compliance.
- Maintain and scale QMS and develop pathways for closing gaps and maintaining compliance.
- Lead regulatory efforts required to align with new regulations and requirements including changes to international standards.
- Interpret Regulatory Authority policies and guidance and integrate them as appropriate in product development, quality, and regulatory activities.
- Provide strategic direction to the quality engineering team with a focus on design assurance and post-market surveillance.
- Lead and scale international product registrations (3-4 countries per year)
- Provide strategic clinical and regulatory input and guidance to cross-functional teams across the organization, including R&D, manufacturing, marketing, and quality assurance
Qualifications:
- Degree in Engineering, Life Sciences, or related fields; Advance degree preferred.
- 10+ years of experience in regulatory affairs in the medical device industry; prior 510(k) submission and EU MDR experience required. Experience with medical devices that include complex software and hardware systems is desirable.
- Proven success building and maintaining quality management system.
- Excellent grasp of all pertinent regulations for medical device design, development, pre-clinical and clinical trials, and commercialization.
- Strong ability to work cross-functionally to advocate for and serve as the voice of regulatory and quality throughout the product life-cycle
- Experience communicating directly with FDA and notified bodies in association with new product submissions and external auditing.
- Positive, energizing, and hands-on leader, with the ability to collaborate in a dynamic start-up environment
