Company Overview
Abbott is a global healthcare leader dedicated to helping people live fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in over 160 countries with a team of 114,000 colleagues.
Working at Abbott:
Career growth opportunities with an international company.
Access to free medical coverage through Health Investment Plan (HIP) PPO.
Excellent retirement savings plan with high employer contributions.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefits.
Recognized globally as a great place to work for diversity, leadership, and innovation.
Division Overview
Global Regulatory Services (GRS) helps ensure access to life-changing technologies by providing strategic and predictable regulatory support to medical device business units.
Position: Senior Manager, Regulatory Affairs
Location: [Specify Location]
Salary Range: $128,000 – $256,000 (may vary by location)
Role Summary:
The Senior Manager, Regulatory Affairs, will combine scientific, regulatory, and business expertise to ensure products meet regulatory requirements. The role focuses on digital health technologies including software, cybersecurity, telehealth, and other digital solutions. This position requires strong understanding of software lifecycle management in a regulated medical device environment and the ability to interpret and apply global regulatory requirements.
Key Responsibilities
Review regulatory submissions involving software components (510(k), PMA, CE marking, technical files).
Develop and implement regulatory strategies for new or modified products.
Ensure digital health submissions align with FDA expectations for high-quality approvals.
Collaborate with internal regulatory colleagues to ensure global compliance.
Provide critical review and support for regulatory submission documents.
Anticipate regulatory obstacles and emerging issues throughout product lifecycle.
Maintain awareness of regulatory legislation, guidances, and policies.
Evaluate preclinical, clinical, and manufacturing changes for regulatory filing strategies.
Provide strategic input, guidance, and risk mitigation recommendations to leadership and development teams.
Manage regulatory trackers and provide training on regulatory strategies and compliance.
Required Qualifications
Bachelor’s degree (science, engineering, or related field) or equivalent experience.
Minimum 8 years in R&D or related areas, with at least 4 years in Regulatory Affairs.
Strong verbal and written communication skills.
Ability to negotiate internally and externally with regulatory agencies.
Preferred Qualifications
Advanced degree (MS, Ph.D., MBA) in science, engineering, or law.
5+ years of experience directly in Regulatory Affairs, ideally with medical devices.
Extensive experience with FDA submissions (510(k), PMA, IDE, Q-submissions).
Strong knowledge of software lifecycle management in regulated environments.
Familiarity with cybersecurity, data privacy, and international regulatory frameworks (FDA, EMA, ISO 13485, GDPR).
Certification in Regulatory Affairs (RAC) is a plus.
Experience leading projects, planning meetings, and managing teams effectively.
Why Abbott
Diverse career opportunities with a global healthcare leader.
Supportive work environment enabling professional and personal growth.
Comprehensive health and wellness benefits for you and your family.
Commitment to employee diversity and inclusion.
Learn more: www.abbott.com
Follow Abbott on Facebook and Twitter.
Equal Opportunity Employer – Abbott is committed to diversity and inclusion in the workplace.
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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King Abdullah Economic City | Rabigh | Khulais | Najran | Riyadh | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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Sweden |Taipei :
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