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. 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.

We are seeking a Regulatory Affairs Specialist to assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations. 

Responsibilities:

• 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.

Qualifications:

• Bachelors 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.