Our client develops and manufactures innovative stand-alone mobile diagnostic X-Ray systems within the medical device industry. The client is new to the market and is currently filing for an IPO. They currently in need of a sharp, adaptable, energetic consultant with an extensive background in both Quality Assurance/Regulatory Affairs to provide support for their existing and new product lines.
Principle Duties and Responsibilities:
The consultant will be joining a small 8 person team, and must be flexible and willing to wear multiple hats on both the QA and RA sides, as they will be the lead of both departments for one specific existing product line. As new products are developed, they will assume the same responsibilities for those as well. The consultant will come from a medical device background and will have a strong background in both Quality Assurance and Regulatory Affairs. On the Quality side, they will be experts in ISO 13485, 21 CFR Part 820 and Part 11. On the Regulatory side the consultant will be experienced with CE Mark Tech Files, and will have a good understanding of APAC and EU regulations. The consultant will also ideally have a technical background and have an understanding of software validation and ISO 9001.
· Medical Device: 5-8 years
· ISO 13485, 21 CFR Parts 820 & 11
· Quality Assurance
· Regulatory Affairs (Domestic & International)
· Verification & Validation Test Protocols
· Technical Software Validation
· X-Ray Devices