Global Regulatory Affairs Manager
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 Global Regulatory Affairs Manager to plan, prepare, and execute U.S. and international regulatory submissions for market expansion efforts. This role will start out as a senior level individual contributor and for candidates who are seeking management responsibilities, there is a potential to grow as a people manager, as the company expands its business.
Responsibilities:
- Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia markets.
- Prepare and submit new global market device applications and amendments.
- Prepare and oversee the review of Traditional 510(k) Premarket Notifications.
- Interact with regulatory agency reviewers as well as distribution partners to facilitate product registrations and third-party license holders.
- Write and maintain EU MDR technical documentation, including change notifications, and lead EU related regulatory activities.
- Lead global regulatory assessments for product and manufacturing process changes via the document control process. Prepare and submit global regulatory product updates, as required.
- 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.
- Interpret applicable standards, regulations, and directives to ensure global regulatory compliance.
- Review product labeling for global compliance.
- Develop regulatory processes that apply to US and international locations.
- Participate in regulatory body audits.
Qualifications:
- Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related fields.
- 8-10+ years of experience with Class II and/or III medical devices, including EU MDR/MDD experience. Devices containing software and hardware systems, preferred.
- Extensive experience writing/authoring US, EU, and other key market submissions.
- Experience with international medical device regulations, standards, and guidance documents including MDSAP, EU MDR, and ISO 13485.
- Excellent regulatory-focused writing skills, communication skills, interpersonal and collaboration skills.
- Attention to detail, and ability to manage and prioritize multiple projects simultaneously.
- Effective time management and outstanding organizational skills.
- Demonstrated capabilities as a people manager, including proven experience delegating and mentoring.
- RAC certification is a plus.
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