Regulatory Affairs Specialist

Regulatory Affairs Consultant

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 implement 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.

This is a remote position and the ideal candidate is located near Mansfield, MA or Waukegan, IL.

Responsibilities

Under direction of manager or more senior RA personnel, support new and modified product development projects to establish and integrate regulatory strategy into project activities.

Assist in preparation 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, help develop international regulatory strategy, and ensure timely execution

Help review design control documents including documents associated with design inputs and design outputs

Under direction of manager, assist in interpreting and evaluating proposed regulations for medical devices

Help maintain regulatory intelligence through continuous monitoring of regulatory landscape

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

Bachelors in related field, or equivalent work experience, preferred

0-2 years of experience, preferred

What is expected of you and others at this level

Apply basic concepts, principles, and technical capabilities to perform routine tasks

Works on projects of limited scope and complexity

Follows established procedures to resolve readily identifiable technical problems

Works under direct supervision and receives detailed instructions

Develops competence by performing structured work assignments

Anticipated hourly range : $30.10 per hour - $38.04 per hour

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
• 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 window anticipated to close : 11 / 14 / 2025

The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity / expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.