Internship

Regulatory Affairs Intern

Confirmed live in the last 24 hours

Lexington Medical

Lexington Medical

51-200 employees

Develops advanced surgical stapling technology

Biotechnology
Healthcare

Bedford, MA, USA

Position requires onsite presence in Bedford, Massachusetts.

Category
Risk & Compliance
Legal & Compliance
Requirements
  • Must be a rising junior or above attending an accredited university majoring in Regulatory Affairs, Biomedical Engineering, or similar
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.

Lexington Medical focuses on surgical stapling technology for hospitals and surgical centers, particularly in bariatric and gastrointestinal surgeries. Their advanced stapling systems aim to improve clinical outcomes by reducing complications and shortening hospital stays. The company maintains high quality through vertical integration and automation in their Massachusetts manufacturing facility. Their goal is to enhance surgical procedures and become a trusted partner for surgeons worldwide.

Company Stage

Series B

Total Funding

$6.6M

Headquarters

Billerica, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Growing demand for minimally invasive surgeries boosts surgical stapling market.
  • Rise of outpatient surgeries offers opportunities in ambulatory surgical centers.
  • Global bariatric surgery market growth aligns with Lexington's focus.

What critics are saying

  • Increased competition from emerging startups threatens market share.
  • Supply chain vulnerabilities could disrupt production of stapling systems.
  • Potential patent litigation risks may impact innovation pipeline.

What makes Lexington Medical unique

  • Vertically integrated, ensuring high quality and control over product development.
  • State-of-the-art manufacturing facility in Massachusetts with latest automation technologies.
  • FDA clearance for Powered Stapling System, highlighting commitment to innovation.

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