Medical Device Regulation Specialist
About Your New Employer:
- Manufacturer of devices and therapies that treat over 70 major health conditions, including heart disease, diabetes, and neurological disorders.
- Join a team that is dedicated to improving healthcare through cutting-edge technology and solutions.
- Work alongside industry experts and contribute to impactful projects.
About Your New Job as MDR Specialist:
- Monitor the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
- Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
- Review and analyse clinical databases for the extraction of ADE data and integrate the data to ensure the creation of a unified database consistent with ADE standardization and internalization.
- Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
What Skills You Need for MDR Specialist:
- Requires broad theoretical job knowledge typically obtained through advanced education.
- Relevant degree required.
- 1-2 years of experience in a similar role.
What’s on Offer for MDR Specialist:
- Competitive hourly rate
- Dynamic and collaborative work environment.
