Sr. Regulatory Affairs Specialist

Cardinal Health

About The Position

Cardinal Health is seeking a Senior 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 support of 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. What Regulatory Affairs contributes to Cardinal Health Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implement regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

Requirements

Bachelor’s degree or equivalent work experience preferred
1-3 years Regulatory Affairs experience, preferably in the Medical Device industry
Strong proficiency in Microsoft Office Applications preferred
Ability to manage multiple projects, while having strong organization skills, problem solving skills and being team oriented.
Strong interpersonal, verbal and written communication skills.
Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes actions to resolve
Applies judgment within defined parameters
Receives general guidance may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy

Responsibilities

Under direction of manager, support new and modified product development projects to establish and integrate regulatory strategy into project activities.
Lead, under direction of manager, 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 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
Under direction of manager, 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.
Assists in the development, maintenance and implementation of regulatory procedures and SOPs