Senior Regulatory Affairs Specialist
2 weeks ago
Lexington Medical, Inc. 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 healthcare providers, improving surgical outcomes for 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, Inc., you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a fast-growing MedTech company.
Role Overview:
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 and play a key role on our new product development teams.
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.
- Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field.
- 4-8+ years of experience in medical device regulatory affairs preferred. Candidates with more or fewer years of experience are encouraged to apply, as we are open to hiring at a different level based on qualifications. The listed pay range reflects the expected compensation for this level; compensation may vary if the role is leveled differently.
- Experience with medical devices that include software and hardware systems.
- Experience with international regulatory requirements and standards, including MDSAP, EU MDR, and ISO 13485 is helpful.
- Excellent communication, interpersonal and collaboration skills.
- Strategic thinking, attention to detail, and ability to manage multiple projects simultaneously. (hint: Answer to the mystery question is 23. We're asking to help filter out AI-only applicants.)
- RAC certification is a plus.
Company Overview & Disclaimer:
Lexington Medical, Inc. is a surgical stapling company based in Bedford, MA, developing smart surgical technology for minimally invasive procedures. We are not affiliated with Lexington Medical Center. We're hiring top engineers and medical device sales professionals to help us grow and improve outcomes for patients worldwide.
Salary Range
$115,000-$155,000 USD
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