Regulatory Affairs Operations Specialist II
1 day ago
Abbott Laboratories is seeking a highly skilled Regulatory Affairs Operations Specialist II to join our team in Sylmar, CA. As a key member of our regulatory operations team, you will be responsible for ensuring compliance with regulatory agency specifications and supporting product market entry.
Key Responsibilities- Prepare Global Trade Services (GTS) licenses for products, countries, and business partners to facilitate shipment and achieve departmental and organizational objectives.
- Manage GTS licenses, additional release authorizations (ARAs), and tender support, adhering to SOPs and regulatory operations activities.
- Provide support for Product and Country Experts in setting up releases for new and modified products globally.
- Act as a regulatory representative, reviewing and analyzing GTS blocked orders, providing guidance and direction on regulatory compliance.
- Monitor email boxes for customer service requests, maintaining a high level of service and follow-through on all communications.
- Bachelor's Degree or equivalent combination of education and work experience.
- 2-3 years of experience in a regulated industry, preferably in regulatory affairs, quality assurance, research and development, or scientific affairs.
- Strong analytical, organizational, and follow-up skills, with attention to detail.
- Ability to manage projects, create timelines, and plans.
- Bachelor's Degree in a science-related field (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, or math).
- Experience in the medical device industry.
- Certification in regulatory affairs (RAC) from the Regulatory Affairs Professionals Society is a plus.
Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary and benefits package, as well as opportunities for career growth and development.
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