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Quality Systems Specialist

  • Job reference: 927956
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 30/09/2019

Orion Group are looking for a Quality Systems Specialist for our multinational medical devices client based in the Cork area on an initial 12-month contract with the potential to extend.

Job Purpose
Customer Quality member responsible for completing Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include the submission of Health Authority Reports and responding to Health Authority Inquiries. This individual is familiar with the regulations and standards for Medical Device Reporting.

The Customer Quality Regulatory Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development, Regulatory Affairs and other functional experts internally. Externally, the role interfaces with Notified Bodies, International Regulatory Authorities, Health Ministries, Surgeon's, and Patients.

Main Responsibilities of the role

  • Submission of initial and final vigilance reports in accordance with MEDDEV 2.12-1 current revision
  • Co-ordinating timely responses to competent authorities and health ministry's regarding product performance
  • Co-ordinating responses to product performance enquiries from surgeons, patients and health care providers
  • Support litigation cases and co-ordinate the provision of performance data to company legal teams
  • Partner with client manufacturing sites and design centres to obtain product performance summaries and data
  • Undertake product performance reviews using available data analysis tools to respond to enquiries
  • Escalate product performance concerns through the established processes
  • Participate in product risk assessments providing input in order to evaluate patient risk as required
  • Representing the client, be pro-active in shaping and influencing regulatory environment working with Healthcare Industry body groups and Forums (ABHI, Eucomed etc.)
  • Attend meetings with health care regulators as required
  • To adhere to the company's procedures as detailed in the SOP manual

Desired Experience and Background of the successful candidate

  • A minimum of a Bachelor's Degree is required
  • Regulatory/Quality Systems experience
  • 3+ years Medical Devices Industries experience
  • Broad experience and knowledge of world-wide quality system regulations (e.g. FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements
  • Master Degree in medical or bio-engineering field would be desirable
  • Conversant with statistical and data analysis techniques would be desirable
  • Project Management experience would be desirable
  • RAC or ASQ certifications a plus
  • Demonstrated proficiency conducting investigations and implementing corrective and preventive actions
  • Ability to work in a cross-functional and matrix environment
  • Actively participates in cross-functional team meetings
  • Knowledge of basic medical terminology
  • Proficient in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint)
  • Ability to interface with technical and non-technical personnel at all organization levels
  • Conversant with statistical and data analysis techniques
  • Excellent organisational and project management skills, ability to effectively manage multiple enquiries and projects
  • Ability to interpret and analyse information coming from multiple global sources and multidisciplinary personnel

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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