[Hiring] Sr. Regulatory Affairs Specialist @Cardinal Health

Role Description

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 or equivalent work experience, 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%.

Requirements

• 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.

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