Regulatory Affairs Associate
Orchid Orthopedic Solutions, LLC - Shelton, CT

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  • Determine optimal regulatory strategies for the client’s needs
  • Work with Orchid Design Engineers and clients to determine appropriate testing regimens.
  • Prepare required regulatory submission documents for presentation to the F.D.A. or foreign regulatory authorities.
  • Communicate with clients and regulatory authorities throughout the approval process
  • Other duties as required.
  • Superior interpersonal, oral and written communication skills
  • Good judgment and problem solving skills, with ability to identify, analyze, and resolve problems in a timely manner
  • Client focused individual who is detail oriented
  • Strong organization and planning skills
  • Encouraging and productive team player
  • Must be proficient in Microsoft Outlook, Word, Excel and PowerPoint
  • BS in Physical Sciences or Engineering
  • Previous experience in the medical device industry and/or Regulatory Affairs is preferred.

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Orchid Orthopedic Solutions, LLC acquires MACDEE, a provider of precision machined and molded plastic products to the medical and industrial...