Regulatory Affairs specialist
Quick Apply Contract 7 hours ago Full Job Description
Responsibilities:
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.
Identify opportunity for regulatory affair processes and drive changes to completion.
Help with our international regulatory team to decipher product skus that can be released to different geography (product release authorization process) Requirements:
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.
Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
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.
Identify opportunity for regulatory affair processes and drive changes to completion.
Help with our international regulatory team to decipher product skus that can be released to different geography (product release authorization process) Requirements:
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.
Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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