Internship
Regulatory Affairs Intern
Summer 2025
Confirmed live in the last 24 hours
Lexington Medical
51-200 employees
Develops advanced surgical stapling technology
Bedford, MA, USA
Position requires onsite presence in Bedford, Massachusetts.
- Must be a rising junior or above attending an accredited university majoring in Regulatory Affairs, Biomedical Engineering, or similar
- 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.
Lexington Medical focuses on surgical stapling technology for hospitals and surgical centers, particularly in bariatric and gastrointestinal surgeries. Their advanced stapling systems are designed to improve clinical outcomes by closing wounds and connecting tissues effectively. The company is vertically integrated, controlling product development and manufacturing to ensure high quality, and has achieved FDA clearance for their Powered Stapling System. Lexington Medical aims to enhance surgical procedures and reduce complications, making them a trusted partner for surgeons globally.
Company Stage
Series B
Total Funding
$6.6M
Headquarters
Billerica, Massachusetts
Founded
2013
6 month growth
↑ 3%1 year growth
↑ 3%2 year growth
↑ 3%
Simplify's Take
What believers are saying
- Lexington Medical's products have been clinically proven to reduce complications and shorten hospital stays, offering substantial benefits to both patients and healthcare providers.
- The company's state-of-the-art manufacturing facility in Massachusetts leverages the latest automation technologies, ensuring high-quality production and operational efficiency.
- Significant milestones like FDA clearance enhance the company's credibility and marketability, potentially leading to increased adoption and sales.
What critics are saying
- The highly specialized nature of their products may limit their market to specific types of surgeries, potentially constraining growth opportunities.
- Dependence on FDA approvals and clinical validations can introduce delays and uncertainties in product launches.
What makes Lexington Medical unique
- Lexington Medical's vertical integration ensures unparalleled quality control and rapid innovation cycles, setting them apart from competitors who rely on third-party manufacturers.
- Their focus on advanced stapling systems specifically for bariatric and gastrointestinal surgeries allows them to specialize and excel in these high-demand areas.
- FDA clearance for their Powered Stapling System validates their commitment to quality and innovation, providing a significant competitive edge.
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