Senior Regulatory Affairs Specialist

1 month ago


Princeton, United States Intellectt Inc Full time

Job Details:

Role: Senior Regulatory Affairs Specialist

Location: Princeton, NJ - 08540

Duration: 12 Months


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

IVD Devices EXP in Regulatory Affairs

Exp with US 510K Submission in the last 5 years

Writing submissions with Cross Functional Teams

Excellent Technical Writing Skills

Good Communication skills

Technical Writing Examples would be preferred


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. "



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