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Regulatory Affairs Manager
- Posted: 19/02/2025
- Salary: Competitive
- Location: Puente de Vallecas, United States
- Job Type: Permanent/Fixed Term
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
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.
- Support new product development by assisting Regulatory Affairs in creating and executing regulatory plans for global product launches.
- Partner 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.
- 8 years' Regulatory 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
Callum Sparkes
Director