Regulatory Affairs Officer
- Sligo, Republic of Ireland
- Regulatory Affairs
I currently have an immediate opening for a Regulatory Affairs Officer for a leading medical device manufacturer located in Sligo.This a family owned business that that is known worldwide with a portfolio of over 5000 products that is going through an exciting time.
This is a permanent position with a competitive salary and comes with fantastic benefits.
What will I be doing as a Regulatory Affairs Officer?
You will prepare and submit Technical files and Design Dossiers, support and coordinate with customers, inter and intra departmental colleagues and Quality Systems/Quality Compliance Manager. You will also be a communication liaison between the manufacturer and the local affiliates or regulatory authorities.
- Compiling Regulatory Technical Files and Design Dossiers in line with current standards and regulations
- Responding to queries raised by the regulatory authorities / customers
- Maintaining regulatory information on database
- Ensures a thorough understanding of the products and their clinical applications.
- Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
- Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
- Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
- Maintains externals standards database, reviews new or revised regulatory standards and provide guidance to the organisation regarding the regulatory
- Compile regulatory information for Management review
What I need to be a Regulatory Affairs Officer?
- Scientific qualification and background preferably B.Sc .or equivalent
- 1-2+ experience in pharmaceutical/ Medical Device industry
- Good communication and inter-personal skills
- Proven problem solving skills
- Good technical knowledge computer skills
- Has Knowledge of regulatory requirements in accordance with ISO13485, MDD93/42/EEC and FDA QSR 21CFR Part 820 as required.
- Knowledge of medical device quality standards and guidance documents
If you meet the above requirements and are interested in hearing more don't hesitate in applying. Don't miss out on this opportunity to become part of a leading company. Please respond with an updated CV
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales