Regulatory Affairs Project Manager
Location: Alameda, California, United States
Category: Regulatory Affairs
About Abbott
Abbott is a global healthcare leader delivering innovative technologies that help people live healthier and fuller lives. With a diverse portfolio covering diagnostics, medical devices, nutrition products, and branded generic medicines, Abbott operates in more than 160 countries and employs over 114,000 professionals worldwide.
Position Overview
The Regulatory Affairs Project Manager plays a critical role in supporting Abbott’s Lingo team by aligning scientific, regulatory, and business strategies to ensure products meet global regulatory requirements. As an individual contributor, this role influences department-level initiatives and acts as an expert resource, supporting the preparation and presentation of regulatory documentation required for worldwide product registration.
This position requires strong regulatory knowledge, strategic project leadership, and the ability to work effectively with cross-functional teams in a fast-paced, regulated environment.
Key Responsibilities
Regulatory Strategy and Planning
Develop new regulatory policies, SOPs, and procedures, and train teams on implementation.
Evaluate regulatory risks associated with division policies and develop mitigation strategies.
Provide regulatory insights during product lifecycle planning and product concept development.
Support multi-country regulatory strategies and update plans based on evolving requirements.
Conduct regulatory due diligence for acquisitions and emerging business opportunities.
Determine global submission and approval requirements and anticipate regulatory obstacles.
Monitor regulatory trends, trade association positions, and emerging issues impacting the business.
Mentor and support regulatory professionals within the team.
Regulatory Operations and Compliance
Ensure regulatory compliance with all applicable corporate and divisional policies.
Identify data needs and ensure appropriate documentation is prepared for global product registrations.
Engage proactively with regulatory agencies and internal partners to drive submission readiness.
Review promotional, labeling, and advertising materials for regulatory compliance.
Support risk assessments, scientific arguments, and regulatory issue resolution.
Cross-Functional Collaboration
Communicate effectively with internal stakeholders, regulatory agencies, and external partners.
Collaborate with cross-functional teams including R&D, Quality, Operations, Scientific Affairs, and Global Regulatory teams.
Lead functional groups in generating necessary data for regulatory submissions.
Participate in project planning, meetings, and cross-regional regulatory coordination efforts.
Documentation and Communication
Write and edit technical, regulatory, and scientific documents.
Manage multiple projects, timelines, and priorities with a high level of detail.
Develop submission-ready documentation including FDA, EU, LATAM, and international regulatory files.
Required Qualifications
Bachelor’s degree in a scientific, engineering, medical, or related field (biology, chemistry, immunology, microbiology, pharmacy, medical technology, pharmacology, mathematics, engineering).
Minimum 4 years of experience in a regulated industry (medical products, nutritionals, etc.).
2–5 years of regulatory affairs experience preferred; related experience in Quality, R&D, or Scientific Affairs may be considered.
Detailed knowledge of regulatory guidelines, global product laws, submission types, and GxPs (GCP, GLP, GMP).
Strong communication skills to work with diverse teams and regulatory agencies.
Ability to manage complex projects, multitask, and apply analytical problem-solving.
Experience in developing regulatory strategies and evaluating scientific data for submissions.
Preferred Qualifications
Experience with LATAM regulatory submissions; Spanish fluency preferred.
Advanced degree (MS, MBA, PhD) in a technical or scientific field.
Certification such as RAC (Regulatory Affairs Certification).
Experience with Class III IDE submissions, PMA submissions, EU Technical Files, or Canada Class III/IV Licensing.
8+ years of experience preparing FDA submissions (PMA, IDE, 510(k)) for Class II/III devices or equivalent international submissions.
Proven ability to lead functional teams within a matrixed, geographically diverse organization.
Why Join Abbott
Comprehensive international career development opportunities.
Free medical coverage through the Health Investment Plan (HIP) PPO for eligible employees.
Competitive retirement plan with strong employer contributions.
Tuition reimbursement, student debt support, and educational benefits.
Globally recognized as a top employer for workplace culture, innovation, diversity, and professional growth.
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