Description
Regulatory Affairs Officer (Medical Devices)Sligo
6 Months Contract +
€45 per hour
Optimus Life Sciences are working with a world leading Biomedical & Medical Device company who're looking for an RA Officer to join the Quality team for a 6-month contract. The role will focus on the preparation and submission of Technical Files and Design Dossiers, offering a great chance for someone to develop their skills and gain experience dealing with stakeholders.
Applicants must have strong communication skills and will be given the opportunity to work as the liaison between the client, manufacturer, local affiliates and regulatory authorities.
The position will be full-time on site and would ideally be starting in early August.
Responsibilities
- Compiling Regulatory Technical Files and Design Dossiers.
- Responding to queries.
- Maintenance of the Regulatory Database.
- 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.
Requirements
- Holds a Scientific qualification at a BSc level or higher.
- 2+ years experience working in Medical Device or Biomedical Industry.
- Has Knowledge of regulatory requirements in accordance with ISO13485, MDD93/42/EEC and FDA QSR 21CFR Part 820.
- Experience working with regulatory documentation.
- Strong communication and English language skills.
- Must be computer literate.
If you're interested in knowing more, please send over a CV - thanks!