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Regulatory Affairs Manager

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Neg
Start date
1 Mar 2023
Closing date
21 Mar 2023

Job Details

On behalf of our client, a global diagnostics company, we are currently recruiting for a Regulatory Affairs Manager.

 

Reporting to the QA/RA Director you will promote Regulatory compliance to avoid product and system non- conformance in all aspects of operations and external audits to avoid problems within the Quality Management Systems.  

 

 

 

Essential Requirements  

 

  • Support, monitor and drive Regulatory requirements throughout product lifecycles Manage global registrations of all company products by ensuring requirements are in place and are maintained through annual reports and updates of changes. Global regulatory support for all labelling claims including Material Safety Data Sheets on all products. Maintain oversight of product labelling activities and provide guidance to ensure claims are meeting internal and external standards Review and ensure current reagent and instrument Technical Files/Design History Files comply with European and international requirements. Provide support for Environmental and other requirements (e.g., REACH, ROHS, WEEE, CLP) Develop and mentor RA staff and others as appropriate according to the RA Manual Work constructively with team members across the sites, as applicable Act as primary advisor on regulatory aspects of product development and change management. Support and engage in the internal and external audit programmes as required Ensure RA support for instruments and reagents Support the Vigilance activities within the QARA Department  Provide Regulatory content for Management Review TCIA & MDC Preliminary Reviews (Change Management)

 

 

   Qualifications

 

  • BSc life sciences degree or equivalent industrial experience At least 5 years’ experience in a technical role in the Medical Device industry, preferably in IVDs Knowledge of FDA QSR, 21CFR820, ISO 13485, HC Medical Device regulations, IVD 98/79/EC, IVD Regulation 2017/746/EU  Quality Auditor 

 

 

Skills and Behaviours 

  • Able to take the initiative and use it to propose and drive solutions •         Ability to analyse and interpret technical data, and technical procedures. Must have excellent written and verbal English skills. Team player – able to give and take direction and to give and receive constructive feedback  Self-motivation with strong work ethic, organizational skills, ability to prioritize, schedule and plan.

 Further details email tdunne@thornshaw.com or call Tina at +353 1 2784701.

 

Thornshaw Scientific is a division 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
Website

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