Regulatory Affairs Specialist
About The Position
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 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. Job Summary The Regulatory Affairs Specialist will support the Medical Solutions Regulatory affairs team. This entry level role is responsible for assisting in regulatory activities associated with new product development and maintenance of business projects. This could include 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.
Requirements
- Bachelors in related field, or equivalent work experience, preferred.
- 0-2 years of experience, preferred.
- Organizational and problem-solving skills a plus.
- Oral and written communication skills a plus.
- Ability to multi-task while maintaining deadlines a plus.
- Ability to travel up to 10% of the time.
- 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.
Responsibilities
- Under direction of manager or more senior Regulatory Affairs 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
