Manager, Regulatory Affairs

Responsibilities

• Lead the development and execution of regulatory strategies for new, modified, and marketed medical devices, ensuring alignment with business priorities, product development timelines, and applicable U.S. and international regulatory requirements.
• Direct the preparation, review, submission, and negotiation of regulatory applications with FDA, Notified Bodies, Health Canada, and other global regulatory authorities, including pre-submission planning, response strategy, and post-submission follow-up to support timely approvals.
• Maintain current knowledge of medical device regulations, standards, guidance documents, and submission requirements; establish and maintain effective relationships with regulatory agencies, internal leaders, and cross-functional stakeholders.
• Provide clear and timely communication to senior management regarding regulatory strategy, submission status, approval risks, emerging regulatory issues, and potential business impact.
• Manage, coach, and develop regulatory affairs personnel by setting clear expectations, providing technical guidance, supporting professional development, and promoting effective collaboration with Marketing, R&D, Quality, Clinical, Operations, and other cross-functional partners.
• Review and provide regulatory guidance for labeling, promotional, educational, and product communication materials to ensure compliance with approved indications, claims, and applicable regulatory requirements.
• Serve as the regulatory lead on product development, lifecycle management, design change, and sustaining engineering teams; assess regulatory impact and ensure required documentation and approvals are completed.

Requirements

• Minimum 8 years of directly relevant Regulatory Affairs experience within the medical device industry. Experience must include hands-on preparation, authorship, review, or management of regulatory submissions such as 510(k)s, Technical Documentation/Technical Files, pre-submissions, international registrations, or related regulatory applications.
• Prior experience supervising, mentoring, or leading regulatory professionals is required. A minimum of 2 years of direct people-management experience, including hiring, performance management, talent development, coaching, and resource planning, is required, with additional years of experience preferred.

Preferred Requirements

• Demonstrated ability to lead regulatory strategy, manage multiple priorities, and translate complex regulatory requirements into clear, practical plans for cross-functional teams.
• Demonstrated ability to meet business timelines, prioritize effectively, and identify regulatory risks and mitigation plans.
• Strong written and verbal communication skills, including the ability to communicate regulatory positions, submission strategy, and business impact to technical and executive audiences.
• Demonstrated sound judgment, decision-making capability, and ability to work independently in a fast-paced, regulated environment.
• Strong working knowledge of FDA medical device regulations, EU MDR, Health Canada, and other international regulatory frameworks.
• Experience supporting audits, inspections, technical documentation, labeling review, design controls, risk management, and product lifecycle management.
• Proficiency with Microsoft Office, multiple ERPs and regulatory information/document management systems.

Education Requirements

• Bachelor’s degree in science, biomedical engineering, engineering, regulatory affairs, or a related technical discipline required.
• Bachelor’s degree preferred.
• Master’s degree, MBA, or Regulatory Affairs Certification preferred.

Physical Requirements

• Ability to sit and/or stand for extended periods during a standard workday and use a computer and standard office equipment.

Benefits

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information. Competitive compensation, excellent healthcare including medical, dental, vision and prescription coverage, short & long term disability plus life insurance -- cost paid fully by CONMED, Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period, Employee Stock Purchase Plan -- allows stock purchases at discounted price, Tuition assistance for undergraduate and graduate level courses.