BS Life Science Jobs at Abbott | Apply Now For The Regulatory Affairs Specialist I Role
Abbott is hiring a Regulatory Affairs Specialist I in Sylmar, California. This role presents an exciting opportunity to collaborate with a global healthcare leader, supporting regulatory processes for product registrations and ensuring compliance. If youโre passionate about regulatory affairs and eager to grow in a dynamic environment, Abbott provides the platform to advance your career.
- Job Position: Regulatory Affairs Specialist I
- Location: United States โ California โ Sylmar
About the Company
Abbott is a global healthcare leader that helps people live more fully at all stages of life. With a portfolio of life-changing technologies in diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott serves people in more than 160 countries. The company is recognized globally as one of the best places to work, with a strong commitment to diversity, innovation, and employee growth.
Job Description
Abbott is seeking a Regulatory Affairs Specialist I to join its team in Sylmar, California. In this role, you will provide regulatory support, ensure compliance, and assist with product registration documentation for U.S. and international markets.
Key Responsibilities
- Support annual reports, FDA submissions, and custom device documentation.
- Manage FDA establishment registrations and related compliance updates.
- Prepare and maintain export documentation, including CFG and COE.
- Provide UDI support for FDA and EU regulatory requirements.
- Manage EU and AU Declarations of Conformity (DoCs).
- Track submissions and approvals across the US, EU, AU, and CA.
- Maintain TUV Appendix ABC information for EU compliance.
- Support certificate management, audit preparations, and regulatory reporting.
- Contribute to product rationalization and notifications of discontinuities.
- Assist with regulatory system updates in Windchill, SAP, and Informatica.
Qualifications
Required:
- Bachelorโs Degree or equivalent combination of education and work experience.
- Strong communication, organizational, and problem-solving skills.
- Ability to work in a fast-paced, matrixed environment.
- Experience in cross-division or enterprise-level settings preferred.
Preferred:
- Bachelorโs degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), engineering, or medical fields.
- RAC certification or equivalent professional recognition.
- Strong analytical skills and regulatory research experience.
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