Senior Regulatory Affairs Specialist

CONMED Corporation • Denver, CO

18d • $70,000 - $100,000 • Onsite

About The Position

The Senior 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 role proactive communication of regulatory changes, fostering trust within the organization. This is an onsite role based in Denver, CO.

Requirements

• Bachelor’s Degree in science, engineering or related field
• 2+ years experience in a Regulatory Affairs role
• Authoring and/or leading regulatory submissions (i.e.: 510(k), EU technical documentation)
• Ability to execute assignments independently as assigned
• Must possess strong organization skills
• Must possess strong written and verbal communication skills.
• Demonstrated ability to handle multiple priorities simultaneously.
• This position is not eligible for employer based sponsorship.

Nice To Haves

• M.S. in a technical field or MBA preferred
• Additional Regulatory certifications preferred
• Experience within the Medical Device industry preferred

Responsibilities

• Assist in executing product registrations for USFDA submission (510(k), CE-mark certificate and other international registrations, which includes creating and maintaining Technical Files and supportive documents.
• Prepare global regulatory files/submissions for product registration as assigned.
• Assist in the review of proposed design changes and ECOs to assess regulatory impact.
• Assemble information required for domestic and international submissions.
• Assist the Specialists in assembly and update of Technical Files and Dossiers.
• Provide timely review of product labeling for regulatory compliance.
• Compile information for Medical Device Listings and Certificates to Foreign Government.
• Research and compile information required for customs and sales force requests.
• Assist as needed with marketing collateral reviews.
• Perform other related duties and special projects as required by management.

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