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.
- 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: email@example.com
CareerWise Recruitment (In Search of Excellence)