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

Director (Clinical Trial Disclosures & Data Transparency)

Our client is a leading global Biopharmaceutical organisation, based in Dublin. The Disclosures & Transparency function resides organisationally within the Regulatory Documentation and Submissions division and is responsible for Clinical Trial Disclosure and Data Transparency activities. These activities include the registration of, and results posting of sponsored clinical trials on appropriate Clinical Trial Registries, the generation and facilitation of clinical trial/clinical product transparency activities and deliverables in accordance with relevant laws, regulations...

Location: Dublin,
Director (Clinical Trial Disclosures & Data Transparency)
Dublin Not Disclosed

Regulatory Affairs Manager (EMEA)

A Regulatory Affairs Manager (EMEA) is required to join a leadingMedical Device organisationin Athlone . Your role: As the Regulatory Affairs Manager you will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for company products globally. Your responsibilities: Primary responsibility for regulatory affairs in the EMEA region. Pursue relevant information pertaining to new developments in regulatory affairs by maintaining contact w...

Location: Roscommon,
Regulatory Affairs Manager (EMEA)
Roscommon 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
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Specialist Cork Not Disclosed
CMC Regulatory Affairs Senior Manager Cork Not Disclosed
CMC Regulatory Affairs Senior Manager Cork Not Disclosed
Senior Associate Regulatory Affairs Dublin Not Disclosed
CMC Regulatory Affairs Senior Manager Cork Not Disclosed
Senior Associate Regulatory Affairs Dublin Not Disclosed
CMC Regulatory Affairs Senior Manager Cork 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.