This is Aleem from Intellectt INC; we’ve got an important role Senior Regulatory Affairs Specialist – Temecula, CA – 92591 with one of our prestigious clients. Interested candidates can please send your updated resume at [email protected]
Role: Senior Regulatory Affairs Specialist
Location: Temecula, CA - 92591
Duration: 08 Months
Description
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.
Skills
Have working knowledge in EU MDR.
Have working knowledge in Regulatory Change Assessment.
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 & Experience:
Must have 3-5 years of experiences in Medical Device Regulatory Affairs