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Engineering & Technical

Job Description

REGULATORY AFFAIRS SPECIALISTS x 2 required by CareerWise Recruitment for our medical device client at their diagnostics division in Co. Longford. Permanent role and 24 month Fixed Term Contract roles available. The REGULATORY AFFAIRS SPECIALISTS x 2 will be working on a project relating to the European Union regulation, REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals).

Role of this position

  • Provide support for Regulatory Affairs related issues to ensure compliance with global regulatory requirements & Quality System regulations.
  • Execute and complete tasks and deliverables for CE marking activities as required according to IVD Directive.
  • Prepare and maintain Technical Documentation for Irish manufactured products.
  • Provide update and maintain status of product registrations and notifications.
  • Provide the required information including legal documentation for country specific Regulatory Affairs contacts to enable and maintain product submissions outside the EU as required.
  • Provide, as required, regulatory input and approval for changes and classification of changes to Device Master Records, Quality System records, labelling etc.
  • Perform regulatory risk assessments and provide approval for Customer and Quality Technical Communications.
  • Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Global & Technical Standards.
  • Maintain ETMS To Do training list including those standards, Directives, and Regulations defined as relevant.

JOB REQUIREMENTS

  • You will have a relevant third level qualification to Degree level.
  • 2-3years experience in Regulatory, Technical or Quality areas within the devices or pharmaceutical industry.
  • Advanced organizational skills and attention to detail.
  • The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
  • The highest levels of integrity in the successful completion of your work.
  • Excellent Communication Skills.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Engineering & Technical

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie