Director of Quality and Regulatory
Class II devices
Are you a strong leader that excels in motivating a team? Do you have an entrepreneurial spirit? A Medical Device company in the St. Charles, IL area is currently hiring for a Director of Quality and Regulatory Assurance.
- Strategy and execution of Quality and Regulatory compliance for the site
- Authoring 510Ks submissions
- Work in a cross functional, Matrix capacity with core project teams to manage life cycle from development to commercialization
- Manage gap analysis and risk assessments
- Interact directly with the FDA on submission responses and information requests
- Collaborating with R&D and Operations around existing and new products
- Possessing a strong ability to influence key decision makers
- Bachelor's in Engineering, Medical, Science, or Regulatory discipline preferred
- Management and supervisory experience
- Technical file authorship
- ISO 13485 - some 2016 regulation exposure - 21CFR 820
- Regulatory experience in 510k authorship
- EtO/Gamma experience: worked through the validation protocols
- MDD to MDR 2020: Strong MDD experience and knowledgeable of MDR 2020
If you would be interested in exploring this exciting opportunity, please apply directly with an attached resume and the best time to reach you.
Sthree US is acting as an Employment Agency in relation to this vacancy.
Good Manufacturing Practices
Corrective And Preventive Actions
Hazard Analysis And Critical Control Points