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RA Analyst III

Waukegan, IL 60085

Posted: 01/25/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 537677 Is job remote?: Yes Country: United States

Job Description

Responsible for the support of new product development and maintenance of business projects. Specific activities include but are not limited to Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), PMA, Technical Files, Design Dossiers Collaborate with internal Cardinal international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution Review design control documents including documents associated with design inputs and design outputs Review product labeling for compliance with global labeling regulations Review advertising and promotional literature for compliance with applicable regulations Interpret and evaluate proposed regulations and advise on impact of such regulations on the business Maintain regulatory intelligence through continuous monitoring of regulatory landscape, identify risks, mitigation, and resolution strategies

Proficiency in US and Europe medical device regulations Strong organizational skills Ability to manage multiple projects Deadline conscious Problem solving skills Team oriented Strong oral and written communication skills

Bachelors Degree in a scientific discipline 6-7 years Regulatory Affairs Experience or equivalent Majority of Regulatory Affairs experience in Medical Device industry preferred

*CO/NYC candidates might not be considered
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