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Medical Device Compliance Specialist
4 weeks ago
ABOUT ORGANOX
We are a leading medical device company dedicated to improving transplantation outcomes. Our innovative technology helps preserve donor livers, reducing organ discard rates and facilitating successful transplants.
SALARY: $65,000 - $80,000 per year, depending on experience and qualifications.
JOB DESCRIPTION
The position of Medical Device Compliance Specialist is responsible for managing regulatory activities within our organization. Key responsibilities include:
- Collaborating with the Global Quality Manager to ensure compliance with reporting and complaints procedures;
- Receiving customer, internal, and feedback complaints, reviewing them for reportability within the regulatory timeframe;
- Complaint reporting, including vigilance reporting and medical device reporting in all applicable territories;
- Management of field safety corrective actions and field safety notices;
- Communication with authorized representatives, importers, and other interested parties;
- Working with the VP Regulatory Affairs to ensure completion of the Annual Report;
- Working with the Regulatory and Quality Team to ensure completion of the post-market report;
- Core team member for nonconformity or design change resulting from a complaint or feedback;
REQUIRED SKILLS AND QUALIFICATIONS
To be successful in this role, you will have:
- A proven track record working within the NHS;
- Experience with Medical Device Regulations (MDR 2017/745) and Medical Device Regulation 2002;
- At least 3 years' experience working within the NHS;
BENEFITS
As an employee of OrganOx, you can expect:
- Competitive compensation package;
- Comprehensive benefits, including healthcare and retirement plans;
- Support for ongoing professional development;
- A commitment to work-life balance;
OTHERS
We are an equal opportunity employer, committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability status, or any other characteristic protected by law.
