Specialist Regulatory Affairs Denver, CO

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.

Minimum Requirements:

• Bachelors Degree in science engineering or related field

Preferred Requirements:

• 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

Other Attributes:

• 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.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

• 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

Know 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 option #5.