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, improving surgical outcomes for patients in a thriving $6B+ Surgical Stapler market.
Rooted in a talent-dense culture, we are committed to innovation, fostering continuous growth, and achieving 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 Global Regulatory Affairs Manager to plan, prepare, and execute U.S. and international regulatory submissions for market expansion efforts. This role will start as a senior-level individual contributor, with potential to grow into a management position as the company expands. The position can be remote in Germany, Switzerland, or the UK.
Responsibilities:
1. Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia.
2. Prepare and submit global market device applications and amendments.
3. Oversee the review of Traditional 510(k) Premarket Notifications.
4. Interact with regulatory agency reviewers and distribution partners to facilitate product registrations and licensing.
5. Maintain EU MDR technical documentation, including change notifications, and lead EU regulatory activities.
6. Lead global regulatory assessments for product and manufacturing process changes; prepare and submit updates as required.
7. Serve as the regulatory voice on cross-functional teams, working with product development and manufacturing engineers to ensure compliance throughout the product lifecycle.
8. Interpret standards, regulations, and directives to ensure global regulatory compliance.
9. Review product labeling for global compliance.
10. Develop regulatory processes applicable to US and international locations.
11. Participate in regulatory audits.
Qualifications:
1. Bachelor's degree in Science, Engineering, Regulatory Affairs, or related fields.
2. 8-10+ years of experience with Class II and/or III medical devices, including EU MDR/MDD experience. Devices containing software and hardware are preferred.
3. Extensive experience in writing and submitting US, EU, and other key market applications.
4. Knowledge of international medical device regulations, standards, and guidance including MDSAP, EU MDR, and ISO 13485.
5. Strong regulatory writing, communication, and collaboration skills.
6. Attention to detail with the ability to manage multiple projects simultaneously.
7. Excellent organizational and time management skills.
8. Proven experience as a people manager, including delegating and mentoring.
9. RAC certification is a plus.
Additional Details:
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Legal
* Industries: Technology, Information, and Internet
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