This position is located in Michigan.

This position is for a medical device startup company. They are looking for an individual who has the ability to set up an entire quality system for the facility. Because this company is in startup mode, they are looking for this individual to have the ability to wear many hats. This person needs to have a strong knowledge of quality assurance as well as strong regulatory experience.

1. Prepares documents and or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide.
2. Maintains and follows proper compliance and quality systems requirements.
3. Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.
4. Determine appropriate regulatory requirements and strategies for The Company including both domestic and foreign activities and provide regulatory consultation to other internal and external entities.
5. Acquire and maintain a current knowledge of federal regulations pertaining to the lawful distribution of products, which include facility registration and device listing.
6. Maintain documentation and a historical record for projects and provide management with updated product status.
7. Participate in task force groups.

Requires a four-year degree in life sciences coupled with 3-5 years’ experience in Regulatory Affairs as well as a Quality background.

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