A Regulatory Shared Services Specialist job in Plymouth, MN is available through Adecco Engineering and Technology. Candidates will be responsible for maintaining compliance to all applicable Medical Device regulations to assure achievement of business objectives and government compliance thorough the annual update of the Technical Files/ Design Dossiers. Duties will include assisting in the FDA Establishment Registrations work, state drug licensing, preparation of submissions for market authorization support for Canada and the rest of the world
Regulatory Shared Services Specialist job responsibilities include:
• Support the preparation and maintenance and response to requests for regulatory information and/ or state licensing.
• Communication with agencies, Notified Bodies, customers, both internal and external to communicate technical information upon request.
• Maintain all regulatory files, both hard and electronic copies, ensuring documentation, registers, directories and lists are complete and up to date.
• Engage others and promote and participate in Environmental, Health and Safety initiatives and focusing on improvements.
• Associates or Bachelor's degree is required.
• Two to Five years of experience in Medical device, drug or biomedical or Compliance Laws, Government Regulations and Import and Export controls.
• Strong technical knowledge of Medical products relevant procedures associated with medical terminology.
• Ability to manage multiple projects.
If you are interested in this Regulatory Shared Services Specialist job in Plymouth, MN then please click APPLY NOW. For other opportunities available at Adecco Engineering and Technical go to www.adeccousa.com. If you have questions about the position, please contact Robert Schemel at 612-656-1090or Robert.Schemel@Adeccona.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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