Manager, Regulatory Affairs

Job Listing No: 9740000

Manager, Regulatory Affairs

Cork – POSITION DUTIES & RESPONSIBILITIES: Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory agencies. Assist in the registration of products and product transfers to Wave 2 Countries. Oversees the preparation and maintenance of regulatory submissions and files for Wave 1 (US and EU) countries including US PMA submissions. Oversees process of obtaining data needed for Wave 2 Countries for China specific transfers. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters. Provides leadership, personnel development, training, coaching, and mentoring for staff especially regarding US and EU regulations. Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Ensures adherence to standard operating procedures and prot… – Permanent – Full-time

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