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Lexington Medical, Inc · 4 weeks ago

Senior Regulatory Affairs Specialist (Senior IC or Manager)

United States

Full-time

Remote

Mid, Senior Level

$115K/yr - $185K/yr

5+ years exp

Lexington Medical, Inc. is a medical device company focused on advanced minimally invasive surgical stapling solutions. They are hiring a Senior Regulatory Affairs professional to lead global medical device submissions and regulatory strategy, partnering closely with R&D, Quality, Manufacturing, and Commercial teams to drive new product development and ensure regulatory compliance.

Health CareManufacturingMedical Device

Responsibilities

Lead and author regulatory submissions for U.S. and international markets, including 510(k)s, PMAs or supplements, EU MDR technical documentation, and design dossiers

Own regulatory strategy and execution for new product development programs from early concept through commercialization

Serve as the regulatory representative on cross-functional product development teams, ensuring regulatory requirements are integrated throughout the product lifecycle

Support ongoing regulatory compliance activities, including change order review, design change assessments, and maintenance of existing clearances and approvals

Review and approve product labeling, instructions for use, and related materials to ensure regulatory compliance

Maintain awareness of evolving global regulations, standards, and guidance, including FDA requirements, EU MDR, MDSAP, ISO 13485, and ISO 14971

Participate directly in regulatory correspondence and interactions with regulatory authorities such as the FDA and Notified Bodies

Partner closely with Quality, Manufacturing, and Commercial teams to support audits, inspections, and day-to-day regulatory operations

Qualification

FDA submissionsEU technical documentationRegulatory strategyPost-market surveillanceInternational regulatory frameworksRAC certificationManage prioritiesCommunication skillsAttention to detail

Required

Bachelor's degree in Engineering, Science, Regulatory Affairs, or a related technical field

Typically 5–15+ years of experience in medical device regulatory affairs

Demonstrated ownership of FDA submissions as well as EU technical documentation

Extensive experience with post-market surveillance, including complaint handling support, vigilance reporting, trending, and regulatory maintenance activities

Experience with complex medical devices, including electromechanical systems and software-enabled products

Working knowledge of international regulatory frameworks and standards, including EU MDR, MDSAP, ISO 13485, and ISO 14971

Strong written and verbal communication skills and the ability to influence cross-functional teams

High attention to detail combined with sound judgment and the ability to manage multiple priorities in a fast-paced environment

Ability to operate independently while partnering closely with engineering, quality, manufacturing, and commercial teams