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Senior Regulatory Affairs Specialist

In Minnesota / United States

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Senior Regulatory Affairs Specialist   

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JOB TITLE:

Senior Regulatory Affairs Specialist

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

St. Paul Minnesota / United States

JOB DESCRIPTION:

Shift Start Time End Time :8:00am -5:00pm
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.

Position Details

POSTED:

Jun 25, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16506540160183150

LOCATION:

Minnesota / United States

CITY:

St. Paul

Job Origin:

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Senior Regulatory Affairs Specialist    Apply

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Shift Start Time End Time :8:00am -5:00pm
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.


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