Regulatory Affairs Professional II
1 week ago
About Abbott Laboratories
Abbott is a global healthcare leader committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, encompassing diagnostics, medical devices, nutritionals, and branded generic medicines.
We serve over 160 countries worldwide, with a diverse team of 114,000 colleagues who strive for excellence in delivering innovative solutions that improve patient outcomes.
The Opportunity
Our Toxicology business unit seeks an experienced Regulatory Affairs Specialist II to join our team. This role will be based in either San Diego, CA or Pomona, CA, and will involve direct responsibility for reviewing and approving labeling and advertising/promotional materials, managing global product distribution, and maintaining regulatory records and files.
Key Responsibilities
- Provide regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.
- Review and approve labeling, advertising, and promotional materials, and oversee translations for country registrations.
- Contribute to developing regulatory strategies for new and modified products to achieve clearance/approval.
- Research 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 information.
- Demonstrate commitment to the Company Quality Management System per ISO, FDA, and other regulatory agencies.
- Show professional behavior with internal/external business associates, reflecting positively on the company.
- Understand the quality consequences of improper job performance and be aware of potential device defects in their area of responsibility.
Requirements
- Bachelor's degree (BS/BA) in any biological science or technical field.
- 2-5 years of experience in Regulatory Affairs, with 1-3 years of progressively responsible positions.
Preferred Qualifications
- 1-3 years of experience in an IVD or medical device manufacturing environment.
- Good knowledge of federal regulations.
- Good understanding of product labeling and related requirements.
- Good knowledge of quality systems in a regulated manufacturing environment.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio.
Salary and Benefits
The estimated annual salary range for this position is $65,900 - $131,900, depending on location. We offer a comprehensive benefits package, including health insurance, retirement savings plan, tuition reimbursement, and education assistance programs. Our commitment to employee diversity and inclusion creates a welcoming work environment.
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