Regulatory Affairs Specialist

The Regulatory Affairs 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 II will maintain active awareness with stakeholders, support a collaborative workplace environment, and participate in ongoing training to raise awareness about implicit biases.Responsibilities:Represent as a RA lead and collaborate with cross-functional teams and key stakeholders to ensure task completionProactively communicate the impact of regulatory changes to stakeholders in a timely mannerDetermine submission and approval requirements for the US and EU regions, and plan to compile, prepare, review, and submit regulatory submissions to the appropriate authorities within specified timeframes (with manager oversight)Establish clear communication and proactive follow-up with health authorities to facilitate reviews and ensure submissions are approved within targeted timeframesCollect and organize information per regulatory requirements for preclinical and clinical data, reports, and other applicable documentationEvaluate the integrity of documentation per applicable regulations or deliverable checklistsUnderstand market-specific regulatory filing requirements based on product type and classificationBuild trust with internal and external stakeholders through clear communication and collaborationParticipate in ongoing training and evaluation to raise awareness about implicit biasesRead/train on ethics policies and procedures and understand individual roles in complianceRegulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirementRequired Experience:Bachelor’s degree, preferably in scientific or technical discipline; or Masters degree in Regulatory Affairs2 years of experience in regulatory affairs preferably with working knowledge of product lifecycle management, design controls, risk management and labeling requirementsPreferred Experience:Communication and project management skills.Proactively develops regulatory expertise Proficiency in Regulatory tools and software, knowledge of market specific requirementsExpected Travel 0-20%This position is not eligible for employer-visa sponsorshipDisclosure as required by applicable law, the annual salary range for this position is $74,200 - $115,000. 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.This job posting is anticipated to close on September 4, 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.Benefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.Competitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance- cost paid fully by CONMEDRetirement Savings Plan (401K)- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan- allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level coursesKnow 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 View phone number on click.appcast.io option #5. #J-18808-Ljbffr