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Job Details

Senior Regulatory Affairs Specialist

Company name
Cardinal Health

Mansfield, MA

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Job Description Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Patient Recovery Regulatory Affairs team.  The selected candidate will provide regulatory support on a range of medical devices which include support of change development projects, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Patient  Recovery business.

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 U.S. 510(k)s, EU Technical Documentation aligned with new EU Medical Device Regulation and STED

Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution

Review pre-clinical documentation with focus on compliance to design control

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


5-7 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

Deadline conscious

Problem solving skills

Team oriented

Strong oral and written communication skills

Other skills:

Fluent in local language required


Travel time required, up to 5% WORKING CONDITIONS:

General office environment

Job Requirements

Company info

Cardinal Health
Website :

Company Profile
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality.

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