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 :
- Preferred candidates in Central or Eastern time zones.
- 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.
Regulatory Affairs Specialist
Assists with other regulatory documentation as required by FDA and individual countries. Prepare global regulatory files/submissions for product registration as assigned. Assist in the review of proposed design changes and ECOs to assess regulatory impact. Assist the Specialists in assembly and upda...
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Assists with other regulatory documentation as required by FDA and individual countries. Prepare global regulatory files/submissions for product registration as assigned. Assist in the review of proposed design changes and ECOs to assess regulatory impact. Assist the Specialists in assembly and upda...
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