Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays.
Tasks include : o Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide.
o Support the preparation of dossiers and submission packages for regulatory agencies, including IVDR Technical Dossiers for CE Mark approval.
- Coordination with partner channel regulatory colleagues to obtain product approvals.
- Organize, update, and maintain regulatory documentation in accordance with department and company procedures including maintaining logs and trackers.
- Maintain positive and cooperative communications and collaboration with all levels of employees and partners
- Request and track document legalization, apostille and requests for certificates from regulatory agencies.
- Process change orders for approval of documentation in electronic records management system
- Perform other related duties and responsibilities, on occasion, as assigned.
- A bachelor’s degree with a preference for majors in Science or Engineering is required.
- Experience and excellent understanding of EU IVD regulation
- Excellent verbal and written communication skills, and attention to detail.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
- Strong verbal communication with ability to effectively communicate at multiple levels in the organization
- Must be able to write clear, understandable technical documentation, i.e. regulatory documentation
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