Lead Regulatory Affairs Specialist

CONMED Corporation • Denver, CO

1d • $104,000 - $163,000

About The Position

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 will maintain active awareness with stakeholders, support a collaborative workplace environment, and participate in ongoing training to raise awareness about implicit biases.

Requirements

• Bachelor’s degree, preferably in scientific or technical disciple.
• 7-9 years of regulatory affairs experience
• Familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations.
• Authored multiple regulatory submissions, such as 510ks, EU MDR, and/or Pre-Sub notifications
• This position is not eligible for employer based sponsorship.

Nice To Haves

• Medical device experience

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 and provide strategic guidance to other RA Staff and project team.
• Able to 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level