Senior Director Regulatory Affairs Jobs in Colorado

Position Summary:

The Senior Director of Clinical Affairs will lead the development of the overall clinical strategy for Advanced Surgical (AS) portfolio, with a focus on AirSeal. This leader will be a critical voice on the AS Leadership team and will support the execution of evidence generation based on the clinical strategy, in partnership with broader ConMed organization. This role is responsible for designing and overseeing clinical trials that support regulatory approvals, market adoption, and post-market surveillance; additionally, the role will support broader KOL mapping and engagement, in partnership with marketing organization. The ideal candidate brings deep expertise in surgical environments, strong leadership, and a proven track record in clinical development within the medical device industry.

Key Responsibilities:

Clinical Strategy & Trial Design

• Develop and implement clinical development plans for surgical devices, including laparoscopic, robotic-assisted, and open surgery technologies.
• Design and oversee clinical trials that demonstrate safety, efficacy, and real-world performance.
• Collaborate with R&D, Regulatory, and Marketing to align clinical strategy with product innovation and commercialization.

Trial Execution & Oversight

• Partner with ConMed Center of Excellence on protocol development, site selection, investigator engagement, and trial monitoring.
• Ensure compliance with GCP, FDA, and international regulatory standards.
• Manage CROs, clinical sites, and vendors to ensure timely and high-quality trial execution.

Evidence Generation & Regulatory Support

• Generate clinical evidence to support regulatory submissions (e.g., IDE, 510(k), PMA, CE Mark).
• Provide clinical input for labeling, risk assessments, and health economics studies.
• Support interactions with regulatory bodies and contribute to submission documentation.

Stakeholder Engagement

• Build relationships with surgeons, hospital systems, and Key Opinion Leaders (KOLs).
• Develop and execute publication plan; oversee clinical data presentations at surgical congresses and publication in peer-reviewed journals.
• Collaborate with Marketing and Medical Affairs to translate clinical insights into strategic messaging.

Leadership & Team Development

• Lead and mentor team of clinical and data leaders.
• Foster a culture of scientific excellence, operational efficiency, and cross-functional collaboration.

Qualifications

Education:

• Advanced degree in Life Sciences, Medicine, or related field (MD, PhD, or equivalent preferred).

Experience:

• 10+ years in clinical development within the medical device industry, with a focus on surgical technologies.
• Demonstrated success in leading clinical trials and regulatory submissions.
• Proven leadership managing third party vendors from selection through execution of MSAs (e.g. CROs, EDC, etc.)
• Experience working with global regulatory agencies and surgical stakeholders.

Skills:

• Deep understanding of surgical workflows and clinical endpoints.
• Strong leadership, communication, and strategic planning abilities.
• Expertise in clinical trial design, biostatistics, and regulatory compliance.
• Ability to manage complex projects and cross-functional teams.

This job posting is anticipated to close on March 16, 2026. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.

This position is not eligible for employer-based sponsorship.

Disclosure as required by applicable law, the annual salary range for this position is $199,100 to $308,500. 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.

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.

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.