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Regulatory Affairs Specialist - Medical Device

Employer
Thornshaw Recruitment
Location
Westmeath
Salary
Upon application
Start date
20 Jun 2019
Closing date
20 Jul 2019

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Job Details

My client, a leading medical device company, currently have a new opportunity for a Regulatory Affairs Specialist. This is a permanent opportunity with the company.

The Regulatory Affairs Specialist is responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for Medical products globally.

Key responsibilities include but are not limited to:

• Apply technical solutions to problem solving

• Apply technical solutions to quality improvement projects

• Use technical writing skills to clearly describe technical information

• Analyse customer complaints, identify trends and execute corrective actions

• Review and assess of change control activities for potential impact on current regulatory filings.

• Maintenance of Regulatory procedures to ensure continued compliance.

• Ensure continual Quality System compliance by adherence to established and evolving internal requirements.

• Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labelling as they relate to registration and commercialization of medical devices.  

• Support Regulatory inspections at the site as directed.

• Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.

• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives

Experience and Qualifications:

  • Engineering/Science qualification with 2+ years of working within R&D/QA/RA in a medical device environment.
  • 2/3 years’ experience in R&D, QA/RA, Validations is essential
  • 2/3 years’ experience in Risk, Clinical and Biocompatibility is an advantage
  • Excellent technical writing experience within a medical device environment is essential
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
  • Travel up to 10%

If you are interested in applying for this role please call Nicola on +353 1 2784671 or email ndunphy@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

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

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

 

Company info
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