We are currently looking to add a Manager of Regulatory Affairs and Quality Assurance to our growing company. We develop Class II Medical Devices for the Plastic Surgery Industry. This person will report to the Stakeholders of the company and will be able to build the RA/QA department. This is a Direct-Hire Position based in Chicago.
The main responsibilities of the Manager of RA/QA will be to develop an original Global Regulatory Strategy for legacy products and new medical devices that are being developed. This person will work cross functionally with the key stakeholders to help bring products to market and maintain that status. This person will also create an original Regulatory Strategy for emerging markets, and authoring the submissions for the products.
The Manager of RA/QA will also be responsible for the ISO 13485:2016 quality system. They will have to maintain and implement the quality system when necessary. The RA/QA Manager will be responsible for the full Life-Cycle Management of these devices. The Manager of RA/QA will be the main point of contact for Audits and interfacing with the Regulatory Agencies/Notified Bodies.
Here are the requirements and expectations:
- Bachelor's Degree in the Life Science, Bioengineering is a Plus
- Ph.D. is Preferred
- 4+ Years of RA/QA Experience with Class II or Class III Medical Devices
- Author of 510(k)'s and Tech Files
- Directly communicated and negotiated with FDA and Notified Bodies
- Experience with Regulatory Strategy for Emerging Markets
- Implemented/Maintained ISO 13485:2016 Quality System
- Must have an entrepreneurial mindset, and able to "wear multiple hats"
Sthree US is acting as an Employment Agency in relation to this vacancy.