Our client, a medical device company in Galway is currently looking to recruit a Senior Specialist Global Post-Market Surveillance for their site.
Reports to: Director, Global Post-Market Surveillance
The Global Post Market Surveillance Senior Specialist leads the Divisional Post Market Surveillance team which supports and guides the Business Units in discharging their regulatory obligations to conduct Post Market Surveillance activities.
Responsibilities and Duties:
- Possesses and applies a broad and increasing knowledge of Quality, and its application within the company, to the completion of moderately complex assignments.
- Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
- Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
- Drives business improvements through continuous improvement initiatives.
- Escalation point for quality related non-conformances and CAPAs.
- Drives compliance cross functionally in alignment with divisional policies and procedures.
The Ideal Candidate:
- Third Level Qualification in related field (Science, engineering or nursing preferable)
- Minimum 8 years of experience in medical device industry with minimum 3 years of progressively responsible positions, including;
- Experience with Post market Surveillance, both active and passive, including the generation of periodic reports.
- Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
- Experience working in electronic complaint management systems
- Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Excellent computer skills including all MS Office applications
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
- Able to travel internationally (approximately 15% annually)
- Experience supporting in-vitro diagnostics products
- Experience managing a global complaint handling functional group for medical device or in-vitro diagnostics
- Broad knowledge of engineering and technical applications applied in development of medical devices useful
For further information on this Senior Specialist Global Post-Market Surveillance role in Galway please contact Orla on 086 0449476/ Talent@hero.ie
Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.