Title: Senior Regulatory Affairs Manager – Abbott Rapid Diagnostics
Locations: Lake Forest, IL or Town Center, San Diego, CA, USA
Employment Type: Full-time
Experience Required: 6+ years in regulatory affairs within life sciences or diagnostics
Company Overview:
Abbott is a global healthcare leader dedicated to improving lives at every stage. With a diverse portfolio spanning diagnostics, medical devices, nutritionals, and branded generics, Abbott serves over 160 countries with innovative solutions. Our 114,000 employees drive healthcare transformation, enabling smarter medical and economic decisions for millions worldwide.
Role Overview:
The Senior Regulatory Affairs Manager will play a pivotal role in Abbott Rapid Diagnostics’ Infectious Diseases Division, overseeing regulatory strategies for new product introductions and compliance activities. This role involves regulatory submissions, labeling, promotional review, and liaison with global regulatory agencies. The position requires 4–5 days in-office work with occasional travel up to 25% domestically and internationally.
Key Responsibilities:
Develop and implement regulatory strategies to ensure timely introduction of diagnostic products in domestic and international markets.
Prepare scientifically sound, complete regulatory submissions, including 510(k), CLIA Waiver, and label/promotional reviews.
Serve as the primary regulatory liaison with internal teams, marketing, research, and regulatory authorities throughout the product lifecycle.
Advise on manufacturing changes, technical labeling, and regulatory interpretations to support product development and commercialization.
Maintain up-to-date knowledge of regulatory requirements in the US and global markets.
Ensure compliance with internal SOPs and external regulations, and document regulatory decisions accurately.
Collaborate with leadership to develop product registration plans for international markets and expedite approval processes.
Qualifications:
Required:
Bachelor’s degree in Life Sciences, Engineering, or related field (or equivalent experience).
6+ years of experience in regulatory affairs within diagnostics, medical devices, or life sciences.
Strong written, oral, interpersonal, and negotiation skills.
Demonstrated ability to manage regulatory submissions and liaise effectively with agencies.
Preferred:
Advanced degree or professional certification in Regulatory Affairs (RA).
3+ years of experience with molecular or lateral flow assays.
Proven leadership and project management skills.
Why Join Abbott:
Global career development and growth opportunities in a leading healthcare organization.
Comprehensive benefits including medical coverage, retirement plans, tuition reimbursement, and more.
Recognized globally for diversity, inclusion, and being a great place to work.
Competitive compensation: base pay $111,300 – $222,700 (location-dependent).
Apply Today:
Join Abbott to advance your career in regulatory affairs while contributing to life-changing diagnostics and global healthcare innovation.
Equal Opportunity Employer:
Abbott is committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, or any other protected status.
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