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