Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Chaska, Minnesota
Are you actively seeking for a new Senior Regulatory Affairs Specialist role in Chaska, MN* I have a contract opportunity with a major biomedical laboratory instrument company and candidates with a Bachelor's degree or higher are encouraged to apply. The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on regulatory programs. The incumbents primary responsibilities will be the evaluation, coordination, preparation and implementation of pre-market Regulatory Affairs activities. If you meet the requirements, please send me your updated resume to Kelly.Hua@Yoh.Com.
RESPONSIBILITIES MAY INCLUDE:
* Administration and setup of template FDA and agency submissions for IVD projects.
* Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans. Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
* Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments. Additionally may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
Bachelors degree in field with 5+ years exp. OR Masters degree in field with3+ years exp.
Medical Technologist background and IVD experience strongly desired.
1) Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics.
2) Author premarket submissions, including 510(k)s and PMAs to the U.S. FDA. Create Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market.
3) Experience in developing effective regulatory strategies and applying regulations to premarket strategies.