Regulatory Affairs Specialist

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Foster City, California

Post: Sat, 25 Mar 2023 06:34:31 GMT

Expires: Sat, 22 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Responsibilities:

Exempt/Non-Exempt: Non-Exempt

Years’ Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs

Have working knowledge in EU MDR

Have working knowledge in Regulatory Change Assessment in

Have working knowledge in US and EU medical device submissions.

Have experience supporting internal and external inspections.

Work cross-functionally and in a matrixed environment.

Requirements:

BA Degree Required

This position will be working with multiple business units to develop, update, and improve regulatory affair processes.

Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Update and develop procedures for regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.