Sr Regulatory Affairs Specialist

Cardinal Health•Mansfield, MA

1d•Remote

About The Position

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. This is a remote position, and the ideal candidate is located near Mansfield, MA or Waukegan, IL.

Requirements

Bachelor’s degree or equivalent work experience preferred.
2+ years Regulatory Affairs experience in the Medical Device industry preferred.
Ability to manage multiple projects, while having strong organization skills, problem solving skills and being team oriented preferred.
Strong interpersonal, verbal and written communication skills are preferred.
Strong proficiency in Microsoft Office Applications preferred.

Responsibilities

Support 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 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.
Assists in the development, maintenance and implementation of regulatory procedures and SOPs.