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

Director of Regulatory Affairs

Our client a global medical device companywho have established a European Centre of Excellence in Ireland are currently seeking a Director of Regulatory Affairs to join their team. The Director of Reg Affairs will support worldwide regulatory submissions and audits outside of USA. The Director of Regulatory Affairs will report to VP of International Operations and will be a dynamic, detail-oriented, self-directed contributor and will spot opportunities to develop and optimize regulatory strategy while managing multiple projects and priorities. The Director of &nbsp...

Location: Galway,
Director of Regulatory Affairs 		Galway Not Disclosed

Director Regulatory Affairs

Director Regulatory Affairs Our client, a growing biotech organisation are currently recruiting for a Director of Regulatory Affairs to join their organisation on a permanent basis. As Director of Regulatory Affairs will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. You will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledge gaps Provide regulatory...

Location: Dublin, Republic of Ireland,
Director Regulatory Affairs 		Dublin Not Disclosed
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Senior Quality and Regulatory Manager Galway Not Disclosed
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Regulatory Affairs Director Career Profile

Regulatory Affairs Director


A strategic role which is responsible for the overall direction of the company, often involved in a smaller company at start-up stage. The spec below refers to an example position in the Medical Device sector

Key Responsibilities

  • Compliance with and adherence to medical device regulations in the geographical areas mentioned.
  • Achieve approval for these 2 products to be sold in new territories, in accordance with Class III Medical Device regulations.
  • Introduce and managed design control and quality systems.
  • Regular meetings with other territories, to collaborate on solutions and current progress. Included in this will be frequent air travel.
  • Dealing directly with relevant local regulatory bodies.
  • Managed Customer Complaints though extensive consultation with physicians and Sales and Marketing personnel.
  • Assisting with research and seeking regulatory approval in relation to possible other clinical indications of the products in various markets.
  • Authored and deliver product presentations to physicians and to sales personnel.
  • Liaise with international colleagues in relation to ongoing clinical monitoring.

Skills / Experience

  • B.Sc. degree in Life Sciences, advanced degree preferred.
  • 10+ years experience in Medical Device Regulatory Affairs, specifically dealing with emerging geographical markets. 4 years in a senior management capacity, preferably internationally.
  • Knowledge of GI / urinary diseases.