- Reference: AJ41921
- Job Type: Permanent
- Location: Offaly, Roscommon, Westmeath
- Category: Science, Pharmaceutical & Food
Quality Assurance Regulatory Affairs, Post Market Surveillance Specialist with French
The Post Market QARA Specialist-French will act as the primary contact for registering confidential complaints and/or product dissatisfaction. This person 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.
This role is responsible for ensuring activities associated with Field Actions are approved, communicated, written and delivered as appropriate. This will include initiation of Field Actions, ensuring compliance to associated regulatory requirements, creation and completion of the necessary paperwork required to complete the Field Action.
The QARA PMS Specialist will be responsible for providing regular status reports to Management and Regulatory Authorities as required.
Key responsibilities of the Post Market QARA Specialist:
Responsibilities will include (but are not limited to) the following:
Supporting the complaint handling process including:
- 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.
- Maintain complaint tracking system.
- Attend/facilitate meetings to resolve Customer Complaints.
- Ensure effective CAPA is taken to help prevent reoccurrence.
Supporting the Field Action process including:
- Ensuring that any Recall strategy provided by a Legal Manufacturer is complied with.
- Ensuring appropriate recall activities are documented, approved and communicated to relevant parties.
- Action Forms in conjunction with the Coordinating Competent Authorities along with Management.
- Collaboration with appropriate personnel to translate the field correction communication and issue of same to Regulatory Authorities (Inc. other CAs, NBs) with their regions along with consignees.
- Coordination of the issue of the Field Notice and reconciliation of Acknowledgement status from consignees.
- Requesting closure of field corrective actions from affected Regulatory Authorities.
- Compilation and Archiving of all records’ associated with the Field Action activity.
- Support other activities in the post-market surveillance system as it develops.
- Fluent/Conversational French
- Engineering/Science Degree with 1 year + experience working within complaints in a medical device environment.
- 1 year’ experience in vigilance reporting
- Excellent technical writing experience within a medical device environment
- 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
- Experience with bio-hazard management/contamination control preferred
- 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
- Approachable and enthusiastic
- Flexible and adaptable.
For Further Information on this role, please contact Nicola Egan on 09064 78104 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie