Regulatory Affairs Manager (Medical Devices)

Republic of Ireland
£51447.43 - £69821.08 per annum + bonus
18 Feb 2013
18 Mar 2013
RE-12452323
Laura Watson
Healthcare
Permanent
Full Time

Title:

Regulatory Affairs Manager ( Medical Device)

Role:
Reporting to the Senior Director of Regulatory Affairs, you will plan, organise, and submit RA submissions in a timely manner, and be responsible for much of the overall regulatory requirements for this Class II & Class III device company. This is an extremely exciting opportunity offering a competitive salary as well as generous benefits.

Responsibilities:
-Evaluate changes to regulatory documents and recommend appropriate filing category
-Represent Regulatory Affairs on innovation teams
-Reviews regulatory and related publications to assure compliance and anticipate future regulatory action
-Coordinate compilation and reviews CMC data package for appropriate and complete documentation
-Interacts with RA colleagues world-wide
-Understanding of CMC
-Analyze regulatory information by determining acceptability of data, procedures, and other product-related documentation

Requirements:
-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree in chemistry or related scientific field
-Minimum 6 years in pharmaceutical/medical devices regulatory affairs, with an emphasis on generics and RA strategy
-Ability to work independently and on teams
-Prior experience interacting with the FDA in the Medical Device industry
-A strong analytic background and chemistry knowledge.
-Strong computer skills in Word, Excel

An excellent salary plus a very attractive benefits package is on offer. This is an urgent requirement so interviews will be immediate. If you are interested in this great opportunity please contact me Laura Watson on 01-8883477 and click apply with an updated CV for immediate consideration.To find out more about Real please visit www.realstaffing.com

To find out more about Real please visit www.realstaffing.com