Sr. Regulatory Affairs Specialist

Job Summary:

The Sr. Regulatory Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the preparation submission and tracking of regulatory documentation. This position requires strong collaboration communication and analytical skills to support product development market access and post-market activities in alignment with global regulatory requirements.

Responsibilities:

• Act as a Regulatory Subject Matter Expert (SME) on various aspects and provide strategic guidance to other RA Staff and project team. Collaborate with quality clinical legal commercial and reimbursement teams to align regulatory strategies.
• Identify regulatory submission and approval requirements and develop a comprehensive plan to compile prepare review and submit documentation to authorities in the US and EU within established timelines. Track and report the status of regulatory actions and submissions to internal stakeholders.
• Understand and apply regulatory requirements for product classification market access and advertising/promotion.
• Participate in inspections audits and post-audit corrective actions.
• Use appropriate sources to justify product classification and regulatory strategies.
• Train others in the use of regulatory systems and tools.
• Raise issues roadblocks and grievances through appropriate channels.
• Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes.
• Communicate new and coming changes facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements.
• Stay current with health authority guidelines and perform regulatory intelligence tasks.

Qualifications:

• Education: Bachelors degree preferably in scientific or technical disciple.
• Experience: 5 years of Regulatory Affairs experience (Medical device industry preferred). Regulatory working knowledge of product lifecycle management design controls risk management and labeling requirements
• Skills: Familiarity with FDA EU MDR and other relevant international regulatory standards and regulations. Authored regulatory submissions such as 510ks EU MDR technical docuntation and/or Pre-Sub notifications.

This position is not eligible for employer based sponsorship.

Disclosure as required by applicablelaw the annual salary range for this position is $80000 - $130000. The actual compensation may vary based on geographic location work experience education and skill level. The salary range is CONMEDs good faith belief at the time of this posting.

Coloradoresidents: 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.

This job posting is anticipated to close on September 1 2025. We may however extend this time period in which case the posting will remain available on . Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.

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.