your search starts here

Close

Sign up for Regulatory Affairs Director jobs email alerts

Email *


Frequency of Alert *

Daily Weekly Monthly

Search results

Job Title Location Salary  
Senior Director, Regulatory Affairs Dublin Not Disclosed
CMC Regulatory Affairs Director Dublin Not Disclosed



Other Regulatory Affairs Jobs

Job Title Location Salary  
Regulatory Affairs Manager Dublin Not Disclosed
Regulatory Affairs Manager Dublin Not Disclosed
Regulatory Affairs Manager Dublin Not Disclosed
Research and Development Compliance Specialist Galway Not Disclosed
Regulatory Affairs Manager Dublin Not Disclosed
Regulatory Affairs Manager Dublin Not Disclosed
Regulatory Affairs Manager Dublin 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.

search jobs


latest jobs

login to your account

forgot your password? click here