Regulatory Affairs Director

4 weeks ago


Bedford, Massachusetts, United States Lexington Medical, Inc. Full time

Lexington Medical, Inc. 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 ever-changing 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.

Key Responsibilities:

  • Develop and Implement Regulatory Strategies: Provide strategic leadership to develop and implement regulatory strategies throughout the product lifecycle aligned to company goals and objectives.
  • Regulatory Compliance: Prepare amendments/supplements, new device applications, 510(k)s, technical documentation (EU MDR), and design dossiers.
  • Internal Audit and Quality Management: Lead internal audit activities for MDSAP, EU MDR, and ISO 13485 compliance, and maintain and scale QMS.
  • Regulatory Efforts and Guidance: Lead regulatory efforts required to align with new regulations and requirements, including changes to international standards, and interpret Regulatory Authority policies and guidance.
  • Strategic Direction and Leadership: Provide strategic direction to the quality engineering team with a focus on design assurance and post-market surveillance, and lead and scale international product registrations (3-4 countries per year).
  • Cross-Functional Collaboration: Provide strategic clinical and regulatory input and guidance to cross-functional teams across the organization, including R&D, manufacturing, marketing, and quality assurance.

Qualifications:

  • Education: Degree in Engineering, Life Sciences, or related fields; Advance degree preferred.
  • Experience: 10+ years of experience in regulatory affairs in the medical device industry; prior 510(k) submission and EU MDR experience required.
  • Leadership and Quality Management: Proven success building and maintaining quality management system.
  • Regulatory Knowledge: Excellent grasp of all pertinent regulations for medical device design, development, pre-clinical and clinical trials, and commercialization.
  • Communication and Leadership: Strong ability to work cross-functionally to advocate for and serve as the voice of regulatory and quality throughout the product life-cycle, and experience communicating directly with FDA and notified bodies in association with new product submissions and external auditing.
  • Leadership and Collaboration: Positive, energizing, and hands-on leader, with the ability to collaborate in a dynamic start-up environment.


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