Provides leadership and guidance to the regulatory affairs team. Prioritizes and develops regulatory strategy and work content in gaining regulatory approvals, re-registrations, and changes to indications and product improvements to listed medical devices, with focused oversight of primary work content related to maintaining and obtaining EU approvals. This may include generating new and/or maintaining/updating existing design dossiers, CERs, and EU databases (EUDAMED). Provide leadership for transition to EU MDR. Manages supporting regulatory staff.
Minimum Work Experence/Educational Requirements
• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Limited exposure to hazardous chemicals used in the manufacture of the product
• Physical demands are typical of an office and classroom environment