Specialist Regulatory Affairs - Denver, CO
About The Position
The Regulatory Affairs Specialist assists the RA team to compile and submit necessary information for domestic and international registration of products marketed by CONMED. Assists with other regulatory documentation as required by FDA and individual countries. Key Duties & 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.
Requirements
- Bachelor’s Degree in science, engineering or related field
- Knowledge of regulatory, quality or similar position.
- 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
- Experience with 510(k) and EU technical documentation 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
