Regulatory Affairs Associate
||Tuesday, June 18, 2019
Assists the Regulatory Specialists 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.
Duties and Responsibilities:
- Assemble information required for domestic and international submissions.
- Assist the Specialists in assembly and update of Technical Files and Dossiers.
- Be familiar with product registration requirements in international markets.
- Initiate Regulatory Strategy forms and Notes to File as required for new and modified products.
- Compile information for Medical Device Listings and Certificates to Foreign Government.
- Maintain Regulatory database.
- Research and compile information required for customs and sales force requests.
- Assist as needed with marketing collateral reviews.
- Prior regulatory experience preferred.
- Associate degree preferred. Additional hands on regulatory affairs experience may substitute for educational requirement.
- Ability to execute assignments independently as assigned. Must possess strong organizational, strong written and verbal communication skills. Must possess demonstrated ability to handle multiple priorities simultaneously.
- Multi-Lingual candidate preferred.
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