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

QA/RA Director -Start Up Medical Device

Our client an early stage start up medical device company are currently seeking an experienced Manager/Director of QARA. The QA/RA Director/Manager will be a key early employee in a valuable leadership position, you will be joining a senior leadership group steering the company’s growth, value & culture. The Director of Quality Assurance & Regulatory Affairs will own & shape the Regulatory & Quality System functions. The appointee will be the main point of contact for regulatory authorities & notified bodies for the marke...

Location: Galway,
QA/RA Director -Start Up Medical Device 		Galway Not Disclosed

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
Other Regulatory Affairs Jobs
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Senior Regulatory Affairs Specialist Dublin Not Disclosed
Clinical Publisher Associate Cork Not Disclosed
Technical Device Regulatory Maanger Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
Technical Device Regulatory Maanger 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.