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. 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.
Job Summary

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.

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

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 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.

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

- May contribute to the development of policies and procedures

- Works on complex projects of large scope

- Develops technical solutions to a wide range of difficult problems

- Solutions are innovative and consistent with organization objectives

- Completes work; independently receives general guidance on new projects

- Work reviewed for purpose of meeting objectives

- May act as a mentor to less experienced colleagues

Anticipated salary range: $80,900 - $127,050

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

- Medical, dental and vision coverage

- Paid time off plan