Regulatory Affairs Representative

General Description:

Ensures regulatory compliance by completing the appropriate filings and documentation pertaining to incidents of injury, product approval and product registration and recall as required by the Food and Drug Administration.

 

 

Essential Functions:

?  Ensure that existing approvals and docs are maintained.

?  Provide input on and review protocol and reports for design verification and validation. 

?  Participate in design reviews of products under development.

?  Responsible for product release approval.

?  Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier, Technical File, and Certificates to Foreign Government.

?  Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

 

 

QUALIFICATIONS:

?  0-2 years regulatory experience in the medical device industry.

?  Bachelor?s degree (B.S. or B.A.) in related field.

?  Previous experience in legal, technical or medically related area preferred.

?  Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time.

?  Must be able to review printed material.

?  Must be able to communicate with others telephonically.

?  Must be able to use common office equipment (e.g. PC, telephone, fax machine, etc.).

?  Ability to understand and explain detailed regulatory compliance programs and/or issues.

?  Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

?  Ability to analyze and resolve non-routine regulatory issues using independent judgment.

?  Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.).

?  Excellent analytical and writing skills.

?  Effective interpersonal communication skills.

?  Effective organizational skills.

?  Excellent independent judgment skills.

?  Self-motivation.

?  Basic PC skills.