Skip to main content

This job has expired

Regulatory Affairs Specialist - Medical Devices

Employer
Thornshaw Recruitment
Location
Westmeath, Leinster (IE)
Salary
Negotiable depending on experience
Start date
18 Aug 2021
Closing date
17 Sep 2021

View more

Discipline
Quality, GMP, Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

My client, a global medical device company based in Westmeath is currently recruiting for a Regulatory Affairs Specialist to join their team. This is a 2-year fixed term contract.

The Regulatory Affairs Specialist, Strategic Manufacturing is responsible for preparing the Technical Documentation to support EU MDR compliance of products undergoing manufacturing transfer. The RA Specialist will also be responsible for compiling registration documents in support product transfer activities; completing risk management activities, transfer and maintenance of technical files/design dossiers for the transfer products.  The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain worldwide Regulatory clearances/approvals. The candidate will report into the Regulatory Affairs Manager, Strategic Manufacturing

KEY RESPONSIBILITES:

 

Key responsibilities will include (but are not limited to) the following:

 

  • Complete the regulatory planning activities for the applicable strategic manufacturing projects.
  • Clearly communicate regulatory requirements for the strategic manufacturing projects to the project managers and program manager.
  • Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during the planning, execution and closure of the projects.
  • Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved.
  • Transfer technical files to the assigned legal manufacturer and maintain the technical files once transferred.
  • Complete risk management and post market surveillance activities to support the technical files at the sending sites until the transfer activities are complete.

ESSENTIAL SKILLS / EXPERIENCE:

  • Engineering/Science qualification with 3 years of working within R&D/QA/RA in a medical device environment.
  • 3 years experience in R&D, QA/RA, Validations – essential
  • 3 years experience in Risk, Clinical and Biocompatibility – an advantage
  • Excellent technical writing experience within a medical device environment - essential

For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert