Principal Regulatory Affairs Specialist

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. Affairs plans, coordinates and implements 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.

Location: This is a remote position, and the ideal candidate will be located near or willing to travel to Waukegan, IL or Mansfield, MA.
Job Summary

The Principal Regulatory Affairs Specialist supports the Medical Solutions Regulatory Affairs team by managing regulatory requirements for international product registrations, developing global regulatory strategies, and supporting U.S. convenience kitting activities. The role leads regulatory efforts for new product development, manufacturing and product changes, regulatory submissions, compliance initiatives, and commercial support. This position works closely with cross-functional teams to ensure products meet U.S., EU, and international regulatory requirements while supporting business objectives and continuous process improvement.
Responsibilities

- Lead regulatory strategy for new and modified product development projects, ensuring regulatory requirements are integrated throughout the product lifecycle.

- Prepare, submit, and maintain global product registrations, including FDA 510(k) submissions, EU Technical Documentation, and International STEDs.

- Collaborate with global and regional regulatory teams to support international market access and ensure timely execution of regulatory strategies.

- Review product labeling to ensure compliance with global regulatory and medical device requirements.

- Monitor, interpret, and assess emerging medical device regulations, providing guidance on business impact and compliance requirements.

- Maintain regulatory intelligence, identify compliance risks, and develop mitigation and resolution strategies.

- Provide regulatory support for customer inquiries, bids and tenders, customs requests, OEM, Private Brand, Presource, and Sustainable Technologies businesses.

- Develop, implement, and maintain regulatory procedures, SOPs, and compliance processes.

- Manage regulatory data, analytics, and reporting through regulatory information management systems, including trend analysis of submission activities.

- Ensure global product and regulatory requirements are effectively implemented and maintained to support ongoing compliance and market access.

- Independently oversees multiple regulatory projects and develops regulatory strategies that optimize and accelerate market access opportunities. Successfully executes projects with limited support, proactively identifying emerging risks, regulatory challenges, and business impacts, while implementing solutions that ensure compliance and achievement of project goals.

Qualifications:

- Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred.

- 5+ years regulatory affairs experience preferred.

- Experience in medical device industry a plus.

- Proficiency in International STED, technical documents, and US FDA medical devices regulations highly preferred.

- Strong organizational and problem-solving skills.

- Strong oral and written communication skills.

- Ability to manage multiple projects while maintaining deadlines.

- Ability to travel up to 10% of the time.

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

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