Full-Time
Regulatory Affairs Specialist
Confirmed live in the last 24 hours
Lexington Medical
51-200 employees
Develops advanced surgical stapling technology
Mid
Bedford, MA, USA
Hybrid position in Bedford, MA.
- Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field.
- 3+ years of experience in medical device regulatory affairs.
- Knowledgeable of FDA regulations and requirements, including 510(k)s.
- Experience with international regulatory requirements and standards, including MDSAP, EU MDR, and ISO 13485.
- Excellent communication and interpersonal skills.
- Ability to work independently and in a team environment.
- Strategic thinking, attention to detail, and ability to manage multiple projects simultaneously.
- RAC certification is a plus.
- Develop and implement regulatory strategies for new and existing products.
- Prepare and submit global product registrations.
- Support regulatory efforts required to align with new regulations (e.g., EU MDR, MDSAP) and requirements including changes to international standards.
- Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
- Interact with regulatory agencies, including FDA and Notified Bodies, to facilitate product approvals and clearances.
- Represent Regulatory Affairs on cross-functional product development and manufacturing engineering teams.
- Guide teams to provide content for US and/or international submissions; participates 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 stands out by being vertically integrated, controlling all aspects of product development and manufacturing to ensure high quality. Their goal is to enhance surgical procedures and provide trusted solutions for surgeons worldwide.
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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