Our client a regulatory consultancy company now have a vacancy for a Regulatory Affairs Advisor.

PURPOSE / KEY RESPONSIBILITIES:

Ownership/ regulatory responsibility for a portfolio of products for nominated client.

Close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.

Proposes and implements effective strategies to minimise the timing of and optimise the commercial viability of product licenses.

Responsibility for the preparation of Package Leaflet User-Test or Bridging Reports.

Builds and maintains strong relationships with EU Competent Authority to ensure ease of access and influence.

Qualifications/Experience:

B.Sc. Minimum or pharmacy primary degree.

Greater than 3 years experience in Regulatory Affairs in the Medical Device industry is essential.

Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.

Rounded knowledge of the national and EU regulatory framework.

Excellent written and oral communication skills.

Ability and desire to progress.

For full Job Spec please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.

Regualtory affairs, regulatory, regulatory affairs advisor, medical device, medical devices