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, maintaining active awareness with stakeholders, supporting a collaborative workplace environment, and participating in 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 changes, facilitate/assist with interpretation to guide product and business compliance with regulatory requirements Act as a Regulatory Subject Matter Expert (SME) on various aspects, providing strategic guidance to other RA staff and project teams, and manage special projects across a spectrum of product lines 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 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 initiatives, participate in training, and assist with 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 : Bachelor's degree, preferably in scientific or technical discipline Experience : 7-9 years of regulatory affairs experience Preferred Qualifications: Medical device experience Other Attributes: Skills : Familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations. Authored multiple regulatory submissions, such as 510(k)s, EUMDR, and/or Pre-Sub notifications This position is not eligible for employer based sponsorship. Disclosure as required by applicable law, the annual salary range for this position is $104,000-$163,000. 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. Benefits: 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 Legal Notice: 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. Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment. #J-18808-Ljbffr CONMED Corporation