The Principal Regulatory Affairs Specialist is 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), Technical Files, and STED
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
Bachelor’s Degree in a scientific discipline
3-5 years Regulatory Affairs Experience or equivalent
Majority of Regulatory Affairs experience in Medical Device industry preferred
Proficiency in US and Europe medical device regulations
Strong organizational skills
Ability to manage multiple projects
Problem solving skills
Strong oral and written communication skills
Fluent in local language required
Travel time required, up to 5%
General office environment
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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