Principal Regulatory Affairs Specialist
About The Position
Cardinal Health's Regulatory Affairs function 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 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. The Principal Regulatory Affairs Specialist will support the Medical Solutions Regulatory Affairs team. They are responsible for regulatory activities associated with new product development and maintenance of business projects. This includes being a regulatory lead for change development projects, new product development, change assessment, US, EU, and international regulatory 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.
Requirements
- 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 US and Europe 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.
Responsibilities
- 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.
- 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 submissions, customs queries, etc.
- Development and implementation of regulatory procedures and SOPs.
Benefits
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
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What This Job Offers
Job Type
Full-time
Career Level
Principal
