Expert Regulatory Specialist
2 days ago
We are seeking an accomplished Regulatory Affairs Specialist to join our Quality and Regulatory Affairs Department.
This is a full-time position that requires exceptional written and communication skills, as well as the ability to work in a fast-paced environment.
About the RoleThe successful candidate will be responsible for ensuring compliance with quality systems aspects, including CAPA management, global procedure review, and participation in cross-site Global Regulatory Affairs initiatives.
- Prepare and maintain technical files in compliance with IVD Directive and IVD regulation as applicable for the EU.
- Act as RA representative on Design Change projects which includes the development and implementation of registration strategies for new product launches.
- Review, preparation and compilation of documentation required for global regulatory submissions.
- Support change management and perform RA support for minor and moderate design changes for the AU product line.
The ideal candidate will have a minimum of 3 years' experience in a QA or RA role within a manufacturing facility and a degree in a Science related field.
BenefitsThis role offers flexible work arrangements, making it an excellent opportunity for those who value work-life balance. The position also provides opportunities for professional growth and development within a dynamic organization.
About UsWe are a company dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
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