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

Director, PVE (Risk Management)

Our client is a global Bio-Pharma with a strong pipeline of products across a range of therapeutic areas from Infectious diseases, Inflammation & Oncology. They are seeking a Director of Pharmacovigilance & Epidemiology (Risk Management) to join a new team in Dublin. This team shall be a Centre of Excellence for global Paediatric clinical trials. The ideal person shall have a healthcare degree with a strong drug safety background. Role/Responsibilities: Signal detection and authorship of signal work-up documents in collaboration with a Medica...

Location: Dublin,
Director, PVE (Risk Management) 		Dublin Not Disclosed

Regulatory Affairs & Quality Manager

Regulatory Affairs & Quality Manager Our client a cardiovascular medical device start-up looking to hire a Quality and Regulatory Affairs manager. The succ

Location: Dublin,
Regulatory Affairs & Quality Manager 		Dublin Not Disclosed
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Senior Associate Regulatory Affairs Dublin Not Disclosed
Regulatory Affairs Specialist Cork 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.