Job Description

SUMMARY OF POSITION:

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices. Job responsibilities include regulatory lead for change development projects, new product development, 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 Medical Solutions business.

SCOPE OF DUTIES/JOB DESCRIPTION:

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 new and modified product development projects to establish and integrate regulatory strategy into project activities.
* Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.
* Collaborate with internal Cardinal Health 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 for medical devices and advise on impact of such regulations to the business
* Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
* Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc.
* Development and implementation of regulatory procedures and SOPs

What is expected of you and others at this level:

* Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
* May contribute to the development of policies and procedures
* Works on complex projects of large scope
* Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
* Completes work independently receives general guidance on new projects
* Work reviewed for purpose of meeting objectives
* May act as a mentor to less experienced colleagues

MINIMUM REQUIREMENTS:

Education:

* Bachelors Degree in a scientific discipline preferred.

Skills/Qualifications:

* 4+ years Regulatory Affairs Experience or equivalent
* Majority of Regulatory Affairs experience in Medical Device industry preferred

Competencies:

* 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

OTHER REQUIREMENTS:

* Travel time required, up to 5%