Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

REQUIRED QUALIFICATIONS

• Bachelor’s degree or an equivalent combination of education and experience
• Minimum 8 years’ experience in R&D or related area; ideally includes 4 years in Regulatory Affairs.
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.

Preferred Qualifications

• Bachelor’s degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields.
• M.S. in a technical area or MBA. A Ph.D. in a technical area or law is helpful.
• At least 5 years’ experience in regulatory affairs; highly preferred with medical devices.
• At least 5 years working directly with the FDA on medical devices
• Knowledge on PMAs, IDEs, 510(k)s: Past experience in strategic thinking, planning, preparing or reviewing and demonstrated experience with US submissions and a solid knowledge of FDA regulations
• Strong understanding of software lifecycle management, including design, validation, and maintenance in regulated environments.
• In-depth knowledge of regulatory frameworks (e.g., FDA, EMA, ISO 13485, GDPR) relevant to software products, especially in healthcare and medical devices.
• Ability to interpret and apply regulatory requirements to software systems, including documentation, risk management, and compliance strategies.
• Familiarity with cybersecurity and data privacy regulations as they pertain to software products
• Experience managing projects, planning and conducting meetings and leading teams to ensure completion of project tasks
• Previous experience with 510k / PMA /IDEs / Q-submissions.
• Must be able to juggle multiple and competing priorities.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to problem solve while being detailed oriented is critical
• Has a sound knowledge of a variety of alternatives and their impact on the business.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $128,000.00 – $256,000.00. In specific locations, the pay range may vary from the range posted

Please refer the Job description for details