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Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

Director of Regulatory Affairs

Would you like to join a leading and successful medical device company in Ireland, to further develop your career? This is an excellent opportunity to work with leading technologies in the medical device industry, in a Strategic Director level role. TheDirector ofRegulatory Affairsis responsible for leading regulatory team, regulatory strategy, systems, and for ensuring that the company's products meet regulatory requirements in markets where they are for sale; including appropriate reporting of adverse incidents where applicable.&n...

Location: Republic of Ireland,
Director of Regulatory Affairs 		Republic of Ireland Not Disclosed
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Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager


This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

  • Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
  • Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
  • Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
  • Regulatory Affairs European project team leader for all new projects
  • Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
  • Identify and recommend areas for cost savings from and Regulatory and compliance perspective
  • Provide Regulatory advice and feedback for all internal company departments and external partners
  • Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations