Strategic Regulatory Affairs Lead – Medical Devices

• 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.

Requirements

• Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred.
• 5-7 years regulatory affairs experience preferred.
• Experience in medical device industry a plus.
• Proficiency in 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.

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Hard Skills

• regulatory strategy
• global product registrations
• 510(k)
• EU Technical Documents
• International STEDs
• design control documents
• regulatory procedures
• SOPs
• US FDA medical devices regulations

Soft Skills

• organizational skills
• problem-solving skills
• oral communication skills
• written communication skills
• project management

Certifications & Qualifications

• Bachelor’s Degree in a scientific discipline