ABOUT ORGANOX:
OrganOx has been transforming organ transplantation since 2008, leveraging ground-breaking normothermic machine perfusion technology in our flagship product, the OrganOx metra. This technology helps preserve donor livers for up to 24 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion, we seek a motivated Complaints Manager to join our team.
Position Summary
The position of Complaints Manager is responsible for managing the regulatory activities for OrganOx Limited and will report directly to the Global Director RA/QA. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete tasks reasonably requested by the Global Director RA/QA.
Major Responsibilities
1. Working with the Global Quality Manager to ensure compliance with reporting and complaints procedures.
2. Receiving complaints (customer, internal, feedback) and reviewing for reportability within the regulatory timeframe.
3. Complaint reporting including vigilance reporting and medical device reporting in all applicable territories.
4. Management of any field safety corrective actions and field safety notices.
5. Communication with Authorized Rep, Importer and any other interested party.
6. Work with the VP Regulatory Affairs to ensure completion of the Annual Report.
7. Work with the Regulatory and Quality Team to ensure completion of the post market report.
8. Work with the Regulatory and Quality Team to ensure trending for management review meetings.
9. Core team member for any nonconformity or design change resulting from a complaint or feedback.
10. Company point of contact for all questions relating to the complaints process and status of complaints and reporting.
11. Ensure customers are kept up to date with the status of complaint or reporting.
Skills and Experience
Proven track record in:
1. Working within the NHS.
2. Medical Device Regulations (MDR 2017/745) and Medical Device Regulation 2002.
Qualifications
The Complaints Manager will have:
1. At least 3 years’ experience working within the NHS.
2. Full training will be given.
At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
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