Regulatory Compliance Professional
6 days ago
Abbott is a leading global healthcare company that focuses on delivering innovative solutions to improve people's lives. Our diverse portfolio of products and services includes diagnostics, medical devices, nutritionals, and branded generic medicines.
Job OverviewThis position offers an exciting opportunity to join our team as a Regulatory Affairs Specialist II in the Toxicology business unit. Based in San Diego, CA or Pomona, CA, you will be responsible for reviewing and approving labeling and advertising/promotional materials, ensuring compliance with US, EU, and international regulations and standards.
Key Responsibilities- Provide regulatory support for diagnostic product development and commercial products, ensuring adherence to relevant regulations and standards.
- Review and approve labeling, advertising, and promotional materials, and manage translations for country registrations.
- Assist in developing regulatory strategies for new and modified products to achieve clearance/approval.
- Conduct research on scientific and regulatory information to develop labeling requirements and review verification/validation and risk management reports for accuracy.
- Evaluate product, manufacturing, and labeling changes for regulatory impact and compliance.
- Develop internal procedures and tools, and conduct informational or training sessions for stakeholders.
- Maintain department files and stay informed about global regulatory developments.
- Bachelor's degree (BS/BA) in any biological science or technical degree.
- 2-5 years experience in Regulatory Affairs with 1-3 years of progressively responsible positions.
- 1-3 years in an IVD or medical device manufacturing environment.
- Good knowledge of federal regulations.
- Good knowledge of product labeling and related requirements.
- Good knowledge of quality systems in a regulated manufacturing environment.
- Proficient with Microsoft Office, including Word, Excel, PowerPoint, and Visio.
We provide a competitive salary range of $65,900.00 – $131,900.00, depending on location and experience. Additionally, we offer a comprehensive benefits package, including free medical coverage via the Health Investment Plan (HIP) PPO, an excellent retirement savings plan with high employer contribution, tuition reimbursement, and education benefits.
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