Regulatory Affairs Specialist

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. This position reports to the QA/RA Manager.

Preferred candidates in Central or Eastern time zones.

• 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

• Compile information for Medical Device Listings and Certificates to Foreign Government.

• Assist the international regulatory teams with submissions by providing timely responses to questions.

• Assist as needed with marketing collateral reviews.

• Perform other related duties and special projects as required by management.

Required Qualifications:

• Bachelor's Degree in science, engineering or related field

• Minimum of 3 years in a regulatory, quality or similar position in the medical device field.

Preferred Qualifications:

• 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

• M.S. in a technical field or MBA preferred

• Additional Regulatory certifications preferred

• Multilingual candidate preferred
  0-20% travel

This position is not eligible for employer-based sponsorship

Disclosure as required by applicable law, the annual salary range for this position is $82,580- 130,080 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:

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 & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.