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Senior Regulatory Affairs Specialist III

Location : Chaska, MN
Hours : Full Time
Travel : No
Relocation : No

Job Description :

Our client’s contribution to healthcare is offering a range of diagnostic solutions, clinical data management tools and process management expertise.  Their goal is to provide solutions improving healthcare around the globe.




If you are looking for an opportunity to contribute your skills and knowledge our client has a contract position available - Senior Regulatory Affairs Specialist III.



  • Plans, coordinates, facilitates, and reports on regulatory programs

  • Administer the complaint program

  • 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

  • Provide assistance to technical departments, manufacturing business centers and suppliers in the creation of clinical data for pre-market notifications

  • Team expert for promotional materials review, experimental designs, data analysis and product labeling


Salary:  $43-46/hr DOE (contract)


Schedule:  M-F 8am – 5pm


Benefits:  Medical and Dental available



Required Qualifications :


  • Bachelors degree in field w/ 5+ years exp

  • OR Masters degree in field with 3+ years exp

  • Regulatory experience – Required!

  • Previous experience in the following – Biochemistry, biomedical, pharmaceuticals, reagents, assays, and/ or IVD – A Plus!


 


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