Manager, Regulatory Affairs

• 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.
• Support departmental procedures regulatory processes audit preparation inspection readiness and continuous improvement initiatives to strengthen regulatory execution and compliance.
• 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.

• 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.

• 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.

• Bachelors degree in science biomedical engineering engineering regulatory affairs or a related technical discipline required. Masters degree MBA or Regulatory Affairs Certification preferred.

• Ability to sit and/or stand for extended periods during a standard workday and use a computer and standard office equipment.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

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

Know someone at CONMED Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA you are encouraged to contact us at option #5.