Senior Manager, Regulatory Affairs

CONMED Corporation; Denver (CO); On-site; USD 139,000 - 215,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare including medical

Short & long term disability plus life

Retirement Savings Plan (401K) with 7%

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED Corporation in Colorado is seeking a Senior Manager Regulatory Affairs to lead global regulatory strategy for medical devices, directing submissions, agency engagements, labeling review, and lifecycle support across markets.

You will partner with R&D, Quality, Marketing, and Operations to mitigate regulatory risks, manage resources, and drive continuous improvement while ensuring compliance with FDA, EU MDR, Health Canada, and other authorities.

Qualifications

• Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or related discipline.
• 8+ years regulatory affairs experience in medical devices including submissions (510(k), technical files).
• 5+ years leading regulatory strategy for new product development and lifecycle management.
• 4+ years of direct people-management experience.

Responsibilities

• Lead global regulatory strategy for product portfolios, including submissions and market-entry decisions.
• Direct preparation, review, and negotiation of regulatory applications with FDA, Notified Bodies, Health Canada, and others.
• Advise senior leadership translating regulatory requirements into practical development timelines.
• Maintain knowledge of regulatory trends and implement expectations across teams.
• Coach and develop regulatory affairs professionals and manage resources.
• Drive cross-functional alignment with Marketing, R&D, Clinical, Quality, and Operations.
• Oversee labeling and promotional materials review for regulatory compliance.
• Lead process improvements, inspection readiness, audits, metrics.
• Report to senior management on strategy, risks, and impact.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Cross-functional collaboration

FDA interactions

Education

Bachelor's degree in science/engineering/regulatory affairs

Tools

Regulatory information systems

Job description

Senior Manager Regulatory Affairs provides senior-level leadership for global regulatory strategy and execution for new, modified, and marketed CONMED medical devices. Directs regulatory submission strategy, agency engagement, labeling and claims review, product lifecycle support, inspection readiness, and regulatory process improvement across domestic and international markets. Partners with senior business, R&D, Clinical, Quality, Marketing, and Operations leaders to anticipate regulatory risks, influence product and portfolio decisions, and build a high-performing regulatory affairs team aligned to business objectives and applicable global requirements.

This is an on-site role, not hybrid or remote

Key Duties and Responsibilities

• Lead and elevate global regulatory strategy for assigned product portfolios, including regulatory pathway decisions, submission plans, approval risks, and market-entry considerations for new products, design changes, and sustaining initiatives.
• Direct preparation, review, submission, and negotiation of regulatory applications with FDA, Notified Bodies, Health Canada, and other global regulatory authorities; ensure responses, commitments, and post-approval obligations are managed effectively.
• Serve as a senior regulatory advisor to business and technical leaders by translating complex requirements into practical strategies that support product development timelines, commercial priorities, and compliant lifecycle management.
• Maintain a forward-looking understanding of medical device regulations, standards, guidance documents, and enforcement trends; assess business impact and lead implementation of regulatory expectations across teams.
• Lead, coach, and develop regulatory affairs professionals and managers by setting expectations, building technical capability, strengthening succession depth, and ensuring resources are aligned to portfolio and business priorities.
• Drive cross-functional alignment with Marketing, R&D, Clinical, Quality, Operations, and Commercial partners to resolve regulatory issues, influence decision-making, and ensure regulatory deliverables are incorporated into project plans.
• Oversee regulatory review of labeling, promotional, educational, and product communication materials to ensure claims, indications, risk information, and supporting documentation meet applicable regulatory requirements.
• Strengthen regulatory affairs procedures, inspection readiness, audit support, metrics, and continuous improvement initiatives to improve execution discipline, compliance, and scalability of the regulatory function.
• Provide clear communication to senior management on regulatory strategy, portfolio status, emerging risks, mitigation plans, approval timing, and potential business impact.

In addition to the main responsibilities listed above the Senior Manager is allowed to use discretion to add further duties and tasks based on the business needs which are not explicitly listed here.

MINIMUM REQUIREMENTS

• Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or a related technical discipline.
• Minimum 8 years of directly relevant Regulatory Affairs experience in the medical device industry, including hands-on authorship, review, or leadership of regulatory submissions such as 510(k)s, Technical Documentation/Technical Files, pre-submissions, international registrations, or related applications.
• Minimum 5 years of experience leading regulatory strategy for new product development, design changes, sustaining engineering, or product lifecycle management in a regulated medical device environment.
• Minimum 4 years of direct people-management experience, including hiring, performance management, talent development, coaching, and resource planning.

PREFERRED REQUIREMENTS

• Master's degree or MBA preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Experience managing regulatory professionals and/or managers across multiple portfolios, locations, or business units preferred.
• Experience interacting directly with FDA, Notified Bodies, Health Canada, and other global regulatory authorities preferred.
• Strong working knowledge of FDA medical device regulations, EU MDR, Health Canada, and other international regulatory frameworks.
• Demonstrated ability to lead regulatory strategy, manage competing priorities, identify approval risks, and develop practical mitigation plans.
• Strong written and verbal communication skills with 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.
• Experience supporting audits, inspections, technical documentation, labeling review, design controls, risk management, and product lifecycle management preferred.
• Proficiency with Microsoft Office, ERP systems, and regulatory information/document management systems preferred.
• Demonstrated ability to lead continuous improvement of regulatory processes, metrics, and inspection readiness preferred.

Physical Requirements

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

ADA Disclosure: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This position is not eligible for employer-based sponsorship.

Disclosure as required by applicablelaw, the annual salary range for this position is $138,700.00 - $215,100.00 USD Annual. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED's good faith belief at the time of this posting.

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 800-929-7176 option #5.