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Job Details

Quality & RA Manager - EMEA Integration Lead

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9976
Closing Date: 10 Jan 19
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

On behalf of our client, a global medical devices company, we are currently recruiting for a QRA Manager – EMEA Integration Lead. This is a permanent, full-time role within the Dublin office.

Requirements:

On behalf of our client, a global medical devices company, we are currently recruiting for a QRA Manager – EMEA Integration Lead. This is a permanent, full-time role within the Dublin office.

MISSION

  • Review, update and Execute quality and regulatory processes at EMEA level
  • Guarantee that regulatory requirements are met in regards to local and national laws and company standards in order to place and/or maintain products on the markets
  • Act as Local Safety Officer for our local authorities as needed
  • Develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in country

KEY TASKS

  • Ensure compliance of company activities to the ISO standard 13485
  • Manage and support internal and external audits and inspections
  • Coordinate corrective and preventive actions
  • Manage documentation of the Quality Management System
  • Ensure regulatory compliance for Medical Devices (MDs): access to the market, distribution of the products, life cycle management, notifications to national competent authorities
  • Review and approve translations of product labeling (e.g., labels, IFU, user manual) and promotional material (external and internal communication)
  • Act as a support for other departments like Commercial and Marketing functions, HE&R department, Customers department (especially for tenders) on regulatory questions, trainings and requests
  • Act as a support for external distributors on regulatory requests
  • Contribute to Regulatory intelligence (involvement on internal and external working group, participation to meetings and congresses)
  • Manage the complaint handling process and coordinate for MDs Field remedial actions, recalls
  • Ensure compliance with national, regional and international regulations and policies.  Interpret the intent of regulations and policies and provide such information to project teams and management
  • Instill and drive a regulatory culture.  Establish and support policies and standards for the measurement of new products
  • Maintain proficiency on regulatory requirements and appropriate network internally and externally
  • Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globally to support education on local regulations

KEY REQUIREMENTS

  • Bachelor’s Degree in Nursing, Engineering, Physical or Biological science or related field of study; MS degree preferred
  • Five (5) to seven (7) years’ experience in the medical industry with at least five (5) years in Regulatory Affairs of Medical Devices
  • Scientific formation +/-master in Regulatory Affairs or MD
  • International clinical and regulatory experience desired;
  • Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, local regulatory body Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations
  • Travel: 25% (predominantly to US HQ and regional offices
  • Occasional weekend/travel work may be required as necessary

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

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

#THR2018

 

Apply for this job: Quality & RA Manager - EMEA Integration Lead

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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