Regulatory Affairs Manager - Life Sciences
Irvine, CA Posted: 1/9/2019
Our client is a global leader of in-vitro diagnostics, diabetes monitoring, and blood transfusions. They are seeking a Regulatory Affairs Manager to join their team of tenured professionals in Orange County, CA.
The Regulatory Affairs Manager is responsible for the strategic leadership, management and oversight of Regulatory Affairs to meet division and customer needs throughout the total product lifecycle while assuring compliance with domestic and international regulatory requirements. Responsibility includes oversight of regulatory activities for multiple sites and a key liaison with agencies and inspectors.
- Bachelor’s degree in Biology, Chemistry, Molecular Biology, Clinical Laboratory Science or related field. Advanced degree is recommended.
- Regulatory Affairs Certification is preferred.
- 8+ years’ relevant regulatory leadership and management experience is required, or an equivalent combination of education and experience working in an FDA QSR and ISO 13485 regulated environment for a medical device manufacturer.
- Demonstrated ability to develop options and pathways to compliance considering customer and regulatory requirements, risk and business needs.
- Extensive knowledge and application of FDA, CE Mark, MDSAP, and global regulatory requirements for diagnostic products that includes new product development and design control activities.
- Background required in the preparation and review of global regulatory submissions including FDA premarket notifications, CE design dossiers and technical files.
- Experience in regulatory authority notifications for adverse events, field safety corrective actions, and other CAPA-related activities.
- Experience in the implementation of new standards and regulations.
Apply now for immediate and confidential consideration! Phenomenal Benefits and Compensation package available.
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