See All Jobs

Manufacturing & Production

Engineering & Technical

Scientific & Laboratory

Executive / Management

Job Description

A Quality Program Manager is required by CareerWise Recruitment for our Cork based multinational client. This is a 12-month contract, and the ideal candidate will have 4-6 years' supervisory experience in Regulatory Affairs within the Med Device/ Pharma Sector.

Role of this position

  • Shape and develop the EU MDR Roadmap and Lead Global Implementation.
  • Lead global quality team to develop EUMDR rollout plan in collaborating with engineering site representative and global EUMDR team for key aspect such as Article 18 Implementation.
  • Understand Multivariant EUMDR strategy and assess impact globally & ensure overall business initiatives interdependences understood, with communication to site stakeholders as required to align position.
  • Ensure all quality deliverables met to achieve successful submission to notified bodies per committed timelines and requirements.
  • Provide executive summary updates to key stakeholders.
  • Lead development of global risk-management strategy to support EUMDR tech file submissions.
  • Review & ensure QS procedures and controls are in compliance to standards such as the QSRs, ISO 13485, etc and comply with the recognized Regulatory Standard.

JOB REQUIREMENTS

  • A minimum of a Bachelors Degree, preferably in Engineering/Science or related technical field, 4-6 years specific experience in a management/supervisory role.
  • Demonstrated project management and project leadership abilities are required.
  • Strong influencer with demonstrated track record of developing strategy and aligning stakeholders and team members to support and deliver.
  • Good knowledge of product/process Risk Management (FDA and ISO standards) is required.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  • EU MDR knowledge and understanding is preferred.

Please call Lauren Cusack today for further information on 087-6489969 or email: lcusack@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.

Apply Now

Manufacturing & Production

Engineering & Technical

Scientific & Laboratory

Executive / Management

Cork Office

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

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie