Senior Global Regulatory Affairs Specialist

Job Description

Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions. 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 Global Regulatory Affairs Specialist to plan, prepare, and execute international regulatory pathways and submissions for global market expansion efforts. This a terrific opportunity for an experienced medical device regulatory professional to grow with our company. Please note that this position is based in the Bedford, MA office.

Responsibilities:

• Develop and implement regulatory filing timelines for new and existing products.
• Prepare and submit new global market device applications and amendments.
• Interact with regulatory agency reviewers as well as distribution partners to facilitate product registrations.
• Write and maintain EU MDR technical documentation and lead EU related regulatory activities.  
• Provide 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.
• Participate in regulatory body audits.

Qualifications:

• Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related fields.
• 5-7+ years of experience in a regulatory affairs role with Class II and/or III medical device, 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.
• RAC certification is a plus.