Sr Regulatory Affairs Specialist

Job Summary

The Sr Regulatory Affairs Specialist will support the Medical Solutions Regulatory Affairs team by providing regulatory expertise across a diverse portfolio of medical devices. This could 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.

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.

Qualifications

• 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.

What is expected of you and others at this level

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

Pay

Anticipated salary range: $66,500 - $88,020

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

Application Information

The application window anticipated to close: 07/10/2026

*if interested in opportunity, please submit application as soon as possible.