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

Director, Regulatory Affairs (Pediatrics/Infectious Diseases)

Our client is a global Biopharma who are establishing a new Peadiatric Centre of Excellence in Dublin, Ireland. This is an exciting opportunity to join HIV and Emerging Viruses Regulatory Affairs where you will provide global regulatory strategic and technical leadership of regulatory activities for pediatric product development. Role/Responsibilities: Responsible for providing strategic regulatory guidance on the development of global pediatric submissions, including those required in the US and EU. Responsible for leading all pediatric-related regulatory activities fo...

Location: Dublin,
Director, Regulatory Affairs (Pediatrics/Infectious Diseases) 		Dublin 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.