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.
• 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.

Experience Required

• 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