(Nurse/Health Care) Medical Device Reg.Specialist-Galway
- Job Reference: NET - 173907
- Date Posted: 6 January 2022
- Recruiter: Headhunt International
- Website: http://www.headhuntinternational.com
- Location: Galway
- Salary: On Application
- Bonus/Benefits: Salary Benefits package
- Sector: Engineering, Healthcare & Medical
- Job Type: Permanent
- Work Hours: Full Time
A Major Multi - National Medical Devices Company in Galway,is seeking to fill the post of
MEDICAL DEVICES REGULATORY COMPLIANCE SPECIALIST
Monitors the company's medical devices surveillance program including the intake from all sources, evaluation, processing, and follow-up on complaints and adverse reports complying with government regulations.
Use clinical knowledge to critically review customer experience events to determine Patient impact.
Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), or adverse reaction data as required by regulatory agencies.
Acts as a liaison internally and with external collaborators to develop processes to meet regulatory reporting requirements.
Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
Support complaint trend analysis and annual post market surveillance reports for various products.
Support complaint handling harmonization initiatives with other sites globally.
Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
Support problem solving initiatives within the department and coach or mentor other team members.
KEY SKILLS & EXPERIENCE
We are looking for a Health care professional, i.e. with a clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) ideally with cardiac experience and preferably with 2-3 years relevant experience in a medical devices or related environment.
We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams.
Experience/understanding of complaint handling or CAPA processes are desirable.
Candidates must be able to think critically and make sound decisions.
Candidates must be focused on patient safety and customer service, set high standards,
instils operational excellence, drive accountability and model ethical behavior.
Candidates must be a good communicator and are fluent in English, both in writing and speaking.
A very attractive Salary/Benefits Package is on offer and negotiable
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland