Senior Regulatory Affairs Specialist

Hello I'm Komal from Intellectt we have an opening for a Senior Regulatory Affairs Specialist in Temecula, CA. Please find the job details and description below and if interested You can reach me at [email protected] or call me at +1(732)-813-9025.

Role: Senior Regulatory Affairs Specialist

Location: Temecula, CA - 92591

Duration: 08 Months

Description

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

Skills

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

Have experience with continuous improvement activities

Education: BA Degree Required

Duties: 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 the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Identify opportunity for regulatory affair processes and drive changes to completion.