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Principal Regulatory Affairs Engineer
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.
- Research, analyze and explain regulations, policies, or procedures
- Maintain data in information systems or databases
- Ensure compliance with regulations
- Advise others on regulatory and compliance matters
- Evaluate applicable laws and regulations to determine impact on company activities
- Provide technical review of data or reports
- Coordinate regulatory documentation and submissions activities
- Assist in obtaining and maintaining government approvals for medical devices
- Identify and interpret relevant regulatory guidelines
- Bachelors in related field, or equivalent work experience, preferred
- 4+ years experience in related field, preferred
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
This is a fully remote / work from home opportunity, but will work on Eastern / Central time zone.
Chicago Metro Area
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.
Job posted: 2022-07-10