Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves surgical outcomes for their patients in a thriving $6B+ Surgical Stapler market.
Rooted in a talent dense culture, we are committed to innovation, foster continuous growth and achieve great heights, together. At 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 Senior Regulatory Affairs Specialist to develop, lead and execute a regulatory strategy for new products and global expansion. This is a terrific opportunity for an experienced medical device regulatory professional to grow with our company.
Responsibilities
- Develop and implement regulatory strategies for new and existing products.
- Prepare amendments/supplements, new device applications, 510(k)s, technical documentation (EU MDR), and design dossiers
- Maintain State of Art to global regulations (e.g., EU MDR, MDSAP)
- Lead regulatory efforts required to align with new regulations and requirements including changes to international standards
- Serve as the voice of regulatory on cross-functional teams, including working with product development and manufacturing engineers to ensure regulatory requirements are incorporated throughout the product lifecycle
- Collaborate with commercial teams to ensure regulatory compliance in product labeling, promotional materials, and advertising materials
- Interact with regulatory agencies, including FDA and Notified Bodies, to facilitate product approvals and clearances
Qualifications
- Bachelors degree in Science, Engineering, Regulatory Affairs, or other technically related field.
- 5-8+ years of experience in medical device regulatory affairs, including prior 510(k) submission and EU MDR experience. Experience with medical devices that include software and hardware systems is helpful.
- Experience with international regulatory requirements and standards, including MDSAP, EU MDR, and ISO 13485.
- Excellent communication, interpersonal and collaboration skills.
- Strategic thinking, attention to detail, and ability to manage multiple projects simultaneously.
- RAC certification is a plus.
