Head of Quality & Regulatory
Onsite
$300-400K
We are working with a very exciting start-up to build their Executive Leadership team by searching for a Head of Quality & Regulatory and Chief Operating Officer.
This company specialise in developing a novel drug-device combo. More details to follow on our call.
How will you make an impact?
- Building a Quality & Regulatory culture within a Start-up
- Supporting international mass commercialisation of Novel Medical Devices
- Be the PRRC - you need to be comfortable being in front of the FDA
- Ensuring successful development, approval and commercialisation
- Lay a Regulatory & Quality roadmap, navigating complex regulatory environments
- Oversee the development and implementation of a robust QMS that meets global standards
- Collaborate closely with the Executive Leadership team in creating a powerhouse
What are we looking for?
- 10+ years of Quality Assurance & Regulatory Affairs experience in the Medical Device field
- Drug-device combination products are highly preferable
- You need to be comfortable in being in front of the FDA and international Regulatory bodies
- Bachelor's degree in Scientific discipline
- Wizard knowledge with Global Regulatory requirements and Quality standards- including ISO, FDA, GMP, GCP and GLP
- Excellent communication, written & verbal
Sounds like you? Apply now.
