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

Regulatory Affairs Manager

Regulatory Affairs Manager Our client a medical devcie multinational currently seeks a Reg Affairs Manager to join their team. Reporting to Senior Director QA/RA the Reg Affairs manager will support the Strategic Manufacturing group to prepare global submission and registration documents in support product transfer activities; complete risk management activities, transfer and maintain technical files/design dossiers for the transfer products. The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain worldwide Regul...

Location: Westmeath,
Regulatory Affairs Manager
Westmeath 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

Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs Our client a multinational healthcare company currently seeks Head of Quality and Regulatory Affairs. Reporting to Ge

Location: Dublin,
Head of Quality & Regulatory Affairs
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Specialist Wexford Not Disclosed
Regulatory Affairs Specialist Wexford Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs Associate Westmeath Not Disclosed
Regulatory Affairs Specialist Wexford Not Disclosed
Regulatory Affairs & Communications Specialist Limerick Not Disclosed

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.