Lead Regulatory Affairs Specialist

The Lead Regulatory Affairs Specialist will serve as the subject matter expert for the Regulatory Affairs team in matters of regulatory procedures and compliance. The Lead Specialist collaborates with cross-functional teams and key stakeholders to ensure the completion of assigned tasks. This role involves proactive communication of regulatory changes fostering trust within the organization. The specialist willmaintainactive awareness with stakeholders support a collaborative workplace environment andparticipatein ongoing training to raise awareness about implicit biases.

Specific Responsibilities:

• Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes
• Communicate new and coming changesfacilitate/assist with interpretation to guide product and business compliance with Regulatory requirements
• Act as a Regulatory Subject Matter Expert (SME) on various aspects andprovidestrategic guidance to other RA Staff and projectteam. Able to manage special projects across a spectrum of product lines
• Identifyregulatory submission and approval requirements and develop a comprehensive plan to compile prepare review andsubmitdocumentation to authorities in the US and EU within established timelines.
• Participate in ongoing training and evaluation to raise awareness about implicit biases
• Propose new policies or revisions to adhere to laws and regulations
• Support leadership in organizational initiativesparticipatein training andassistwith tracking progress and outcomes
• Stay current with health authority guidelines and perform regulatory intelligence tasks
• Understand basic regulatory requirements of market access in target markets

Minimum Qualifications:

• Education :Bachelorsdegree preferably in scientific or technical disciple.
• Experience :7-9years of regulatory affairsexperience

Preferred Qualifications:

• Medical device experience

Other Attributes:

• Skills :Familiarity with FDA EU MDR Health Canada and other relevant international regulatory standards and multipleregulatory submissions such as510ks EUMDRand/orPre-Subnotifications

This position is not eligible for employer based sponsorship.

Disclosure as required by applicablelaw the annual salary range for this position is $104000-$163000. 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 June 3 2026. 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.

Required Experience:

IC