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Regulatory Affairs Specialist

3 months ago

Fremont, United States Integrated Resources, Inc ( IRI ) Full time

Job Description:

Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Tasks include:

Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide.

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.


Keys to Success:

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

Proficient in MS applications (Excel, Word, Outlook).

This position is on site at Fremont, California facility