What are the responsibilities and job description for the Regulatory Affairs Manager position at Catalyst Life Sciences?
Opportunity to take up a newly created position with a worldwide in-vitro diagnostics company in Mira Mesa. Leading a team of 3 Senior Specialists, you'll be guiding them through regulatory strategy and initiatives, while taking on some of your own projects when you see fit.
Responsibilities
- Provide leadership and guidance to the Regulatory Affairs team in assessing the regulatory impact of changes on existing market authorizations.
- Oversee regulatory submissions for product changes and ensure compliance of labeling, advertising, and promotional materials.
- Collaborate with leadership and cross-functional teams (R&D, Project Management, Marketing, etc.) to set priorities and goals for design, product changes, international registrations, and promotional material reviews. Promote effective team collaboration.Suppor
- t new product development by assisting Regulatory Affairs in creating and executing regulatory plans for global product launches.Partne
- r with regional teams to ensure comprehensive regulatory compliance and approvals across various geographies. Oversee submission preparation (e.g., 510(k)s, IVDR) and manage communications with Regulatory Agencies.Lead
- regulatory intelligence efforts by monitoring global regulatory changes, maintaining knowledge of relevant regulations, and analyzing emerging standards.Experience
equired8 years' Reg
ulatory Affairs experience, predominantly in the IVD space.5 years' of management and team leadership experience, including day-to-day management as well as yearly performance reviews and team development goals.Ability and desire to work onsite in Mira Mesa
