Regulatory Affairs Specialist – Abbott, Alameda, CA (On-site)
Job Summary:
Abbott, a global leader in healthcare innovation, is seeking a Regulatory Affairs Specialist to join its team in Alameda, California. This is an exciting on-site opportunity to provide regulatory support in evaluating and reviewing labeling, advertising, and promotional materials for medical device products. The role offers exposure to global regulatory submissions and cross-functional collaboration with marketing and product development teams.
Key Responsibilities:
Review and analyze product labeling, promotional, and advertising materials.
Collaborate with Marketing to ensure promotional content meets regulatory requirements.
Provide regulatory strategy and compliance input during promotional content development.
Assist with Regulatory Affairs SOP development and periodic reviews.
Support regulatory activities for new product introductions (NPI) and on-market products including 510(k), PMA, and international submissions.
Ensure product compliance with post-marketing approval requirements.
Communicate content and approval needs to cross-functional teams.
Maintain accurate documentation for regulatory assessments and communications.
Required Skills & Qualifications:
Bachelor’s Degree in Science (Biology, Chemistry, Engineering, or related field) or equivalent education/experience.
2-3 years of experience in regulated industries (medical products, nutritionals).
Understanding of regulatory policies, standards, requirements, and precedents.
Familiarity with FDA regulations, GxPs (GCP, GLP, GMP), promotional guidelines, and international regulatory policies.
Excellent verbal and written communication skills.
Strong project management, organizational, and analytical abilities.
Ability to work in cross-functional, global teams and handle multiple priorities.
Preferred Qualifications:
1+ years of Regulatory Affairs or Quality experience in Medical Devices.
Experience with labeling, advertising, or promotional material reviews.
RAC certification is a plus.
Proficiency in MS Word, Excel, PowerPoint, Visio, and SharePoint.
Perks & Benefits:
Competitive base salary: $79,500.00 – $138,700.00 annually.
Comprehensive health insurance including free medical coverage under HIP PPO.
Excellent retirement savings plan with employer contribution.
Tuition reimbursement and student debt assistance programs.
Career development in a global healthcare organization.
Recognized as a top employer for diversity and innovation.
Company Description:
Abbott is a world-renowned healthcare company delivering life-changing medical technologies in diagnostics, medical devices, nutrition, and branded generics. With a presence in over 160 countries, Abbott is committed to enhancing life quality through innovation and excellence in healthcare.
Work Mode:
On-site – Alameda, California, USA
Call to Action:
Take the next step in your regulatory affairs career. Apply now and join Abbott’s leading medical device division to make a meaningful impact on global healthcare innovation!
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