Sr. Regulatory Affairs Specialist

Hobbsnews; Illinois; Remote; USD 76,000 - 110,000; Full time

Job summary

A leading company in healthcare is seeking a Regulatory Affairs professional in Illinois. The role involves developing regulatory strategies, maintaining compliance with regulations, and collaborating on product development projects. Candidates should have a relevant Bachelor's degree and prior experience in Medical Device Regulatory Affairs. A range of benefits, including medical coverage and paid time off, is offered.

Benefits

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Flexible spending accounts (FSA)

Short- and long-term disability coverage

Paid parental leave

Healthy lifestyle programs

Qualifications

• 2+ years’ experience in Medical Device Regulatory Affairs/Quality.
• Certification in regulatory affairs program preferred.
• Effective project management and communication skills.

Responsibilities

• Collaborate on new and modified product development projects.
• Maintain regulatory information for customer queries and submissions.
• Support preparation and maintenance of global product registrations.

Skills

Project Management

Communication

Problem-solving

Collaboration

Education

Bachelor's in related field

Job description

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.

Responsibilities

• Collaborate with internal Cardinal regional regulatory partners on new and modified product development projects, to establish and integrate international regulatory strategy into project activities and ensure timely execution.
• Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc.
• Provide regulatory support to OEM, Private Brand, Presource, and Sustainable Technologies businesses and range of medical devices.
• Maintain regulatory data, intelligence, and analytics through use of CAH regulatory information management systems, including trend analysis of critical regulatory submission related activities, and generate needed reports.
• Support preparation / maintenance of global product registrations with focus on STEDs.
• Support development, maintenance and implementation of regulatory procedures.
• Under direction of manager, assist in interpreting and evaluating proposed regulations for medical devices
• Supports all pertinent activities to ensure global product and regulatory requirements are accounted for and implemented in a timely manner.

Qualifications

• Bachelors in related field, preferred
• 2+ years’ experience in Medical Device Regulatory Affairs/Quality experience preferred
• Certification in regulatory affairs program preferred
• Effective project management skills
• Effective oral and written communication skills
• Effective problem-solving skills
• Ability to create cross-functional partnerships
• Ability to work collaboratively in a team environment
• Travel Time required, up to 10%

What is expected of you and others at this level

• Applies basic concepts, principles, and technical capabilities to perform routine tasks
• Works on projects of limited 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

Anticipated salary range:$76,7200 - $109,500

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:7/25/2025 *if interested in opportunity, please submit application as soon as possible.

The salary 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.

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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

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.