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Details

Post Market Surveillance Specialist


Reference:CC/HQ00001356 Location: Westmeath
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Customer Complaints

Post Market Surveillance Specialist

An opening has arisen with our medical device client in the midlands for a Post Market Surveillance Specialist. The successful candidate will act as the primary contact for registering confidential complaints and/or product dissatisfaction. He/She will receive, answer and document customer complaints, telephone or written, on all products and enter complaint information as required into an electronic complaint handling system and ensure the company is positioned at all times as a key preferred supplier within the medical devices space. He/She will be responsible for ensuring activities associated with Field Actions are
approved, communicated, written and delivered as appropriate. The candidate will be responsible for providing regular status reports to Management and Regulatory Authorities as required.

Role/Responsibilities
- Receive and log product complaints from a variety of sources.
- Document and coordinate the investigation of product performance issues
- Coordinate and/or perform complaint investigation, ensure related follow-up activities
- and document investigation findings and results
- Provide support on failure evaluation of returned products.
- Follow up on outstanding evaluations to ensure timeliness and regulatory compliance.
- Support Adverse Event Reporting Regulatory Requirements
- Under limited supervision draft responses to specific product complaint and vigilance
- report queries from Competent Authorities.
- Monitor customer complaints and provide immediate feedback to concerned personnel
- when critical issue is detected.
- Maintain complaint tracking system
- Prepare complaint trending reports
- Attend/facilitate meetings to resolve Customer Complaints
- Ensure effective CAPA is taken to help prevent reoccurrence

Skills/Experience
- Engineering/Science qualification with 2/3 years of working within complaints in a
- medical device environment.
- 2/3 years experience in vigilance reporting – essential
- Excellent technical writing experience within a medical device environment – essential
- Good knowledge of the Medical Device Directive and familiarity with its transposition
- into national legislations within Europe as it affects complaint management.
- Good working knowledge of the Quality System Regulations as they pertain to
- customer complaints.
- Attention to detail and accuracy – essential
- Ability to work well under deadlines and pressure
- Problem solving skills for developing creative solutions and meeting objectives are
- required.
- Skills that enable coordination of data, including MS-Office (primarily PowerPoint,
- Word, MD Project, Outlook and Excel);
- Excellent analytical ability
- The ability to prioritize tasks and be able to manage several projects and tasks
- simultaneously; and the ability to interface with all levels of management.
- Behaviours / Values
- Approachable and enthusiastic .Flexible and adaptable.

If you would like further Information you can contact the recruiter directly:

Conor Cronin | Tel: +353 (0) 1 5079258