Associate Director, Regulatory Affairs – Digital Health
Division: Global Regulatory Services (GRS), Leveraged Services
Company: Abbott
Location: [Insert Location]
Base Pay Range: $146,700 – $293,300 (may vary by location)
About Abbott
Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. With 114,000 colleagues serving in more than 160 countries, our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines.
Why Work at Abbott
At Abbott, you can do work that matters while growing your career and caring for yourself and your family. We offer:
Career development opportunities with a global company.
Free medical coverage under our Health Investment Plan (HIP) PPO medical plan (eligible next calendar year).
Excellent retirement savings plan with high employer contributions.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit.
Recognition as a Fortune Most Admired Company and one of the best workplaces for diversity, working mothers, female executives, and scientists.
The Opportunity
We are seeking an Associate Director, Regulatory Affairs to join our Global Regulatory Services division within Leveraged Services.
This role focuses on digital health technologies (software, cybersecurity, telehealth, digital solutions, etc.) and requires strong expertise in software lifecycle management in the regulated medical device environment.
You will:
Serve as an expert resource for regulatory requirements related to digital health.
Support strategic initiatives, submissions, and regulatory policy evaluations.
Collaborate with internal regulatory teams and global health authorities (e.g., FDA CDRH).
Provide leadership in interpreting regulatory requirements and guiding business units toward compliance and successful submissions.
Key Responsibilities
Regulatory Submissions: Review and support submissions involving software components (510(k), PMAs, CE marking, technical files).
Strategy Development: Partner with business units to develop regulatory strategies for new products or changes, especially with FDA.
Document Review: Provide critical review of documents necessary for submissions.
Compliance: Ensure digital health submissions address FDA expectations with strong risk mitigation.
Stakeholder Collaboration: Work with BU RA to resolve deficiencies, influence decision-making, and anticipate regulatory challenges.
Regulatory Monitoring: Maintain awareness of changing legislation, regulations, and guidance; communicate updates internally.
Risk & Safety: Evaluate regulatory risks, preclinical/clinical/manufacturing changes, and recommend solutions.
Leadership Reporting: Provide high-level summaries of submission-related issues to leadership.
Required Qualifications
Bachelor’s degree.
5–7 years of experience in a regulated industry.
Strong verbal and written communication skills, including negotiation with regulatory agencies.
Preferred Qualifications
Bachelor’s degree in science, math, engineering, or medical fields. Advanced degree (M.S., MBA, Ph.D., or Law) desirable.
At least 5 years’ experience in regulatory affairs, preferably with medical devices.
Direct FDA experience with medical device submissions (510(k), PMA, IDE, Q-submissions).
Strong knowledge of FDA regulations and global frameworks (FDA, EMA, ISO 13485, GDPR).
Experience in software lifecycle management, including design, validation, and maintenance in regulated environments.
Familiarity with cybersecurity and data privacy regulations for healthcare software.
Proven ability to manage projects, lead teams, and juggle multiple priorities.
Certification such as RAC (Regulatory Affairs Certification) is a plus.
Additional Information
Learn more about Abbott’s health and wellness benefits: www.abbottbenefits.com
Follow Abbott:
Website: www.abbott.com
Facebook: facebook.com/Abbott
Twitter: @AbbottNews, @AbbottGlobal
Abbott is an Equal Opportunity Employer committed to diversity and inclusion.
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