Regulatory Affairs Intern

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 and has yielded 3x revenue growth in the last two years. 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.

Program Overview:

Lexington’s Summer Intern Program is intended to attract undergraduate and graduate college students who are studying Biomedical Engineering, Regulatory Affairs, or other related fields. You will be given the opportunity to meaningfully contribute to the progress of Lexington and its products, while gaining business acumen and real-world experience which will better prepare you to continue to make impactful contributions throughout your career.

Education:  Must be a rising junior or above attending an accredited university majoring in Regulatory Affairs, Biomedical Engineering, or similar

Location: Bedford, Massachusetts

Responsibilities:

• Participate in the development and implementation of regulatory strategies for new and existing products.
• Prepare global product registrations.
• Support the maintenance of regulatory files and documentation to ensure compliance
• Support regulatory efforts required to align with new regulations (e.g., EU MDR, MDSAP) and requirements including changes to international standards.
• Review product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
• Represent Regulatory Affairs on cross-functional product development and manufacturing engineering teams. Guide teams to provide content for US and/or international submissions; participate in design reviews as needed.