Interim RA/QA Manager
Regulatory Affairs/Quality Assurance Manager - IVD
About the Company:
A medium-sized diagnostic company, located in San Diego CA, has geared their resources into creating antibody test kits for COVID-19. They are currently seeking an interim RA/QA Manager who can commit 40 hours/week, with partial remote flexibility, for a 6-month contract.
About the Role:
The individual in this role will provide regulatory affairs support and guidance for new and on-market products in both domestic and international markets. The individual will oversee 2-3 direct reports, so management experience is required. Submissions experience in the US, EU, and Health Canada is also necessary, as the RA Manager will be providing regulatory strategy throughout the submissions processes.
Your skills and experience
- At least 6 years' diagnostic experience with a combined knowledge of quality and regulatory
- Highly knowledgeable with FDA regulations and ISO 13485
- International submissions experience with Health Canada and IVD Directive required
- Experience managing a team and enjoys developing direct-reports
- Outstanding communication and organization skills
You are highly knowledgeable in the IVD field with knowledge in both regulatory affairs and quality assurance. You are seeking a project where you can utilize your people skills and apply your technical knowledge, making a difference in the COVID-19 diagnostic efforts. You have led IVD submissions in the US and internationally, have the go-getter mentality, and are excited about working with a great team on a relevant cause.
Sthree US is acting as an Employment Business in relation to this vacancy.