Sr. Regulatory Affairs Specialist
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 109,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Lake County, Illinois currently has an opportunity for a Senior Regulatory Affairs Specialist.
WHAT YOU’LL DO –
- Combine scientific, regulatory, and business knowledge to ensure products that are developed, manufactured, or distributed meet required regulations in international and US markets.
- Support project teams to obtain worldwide regulatory approval or clearance for Clinical Chemistry products and provide regulatory support to ensure compliance with all FDA and international regulatory requirements.
- Review on-market product changes and assess worldwide regulatory impact.
- Assist in developing regulatory strategies for on-market products and provide registration impact assessment for design changes throughout the product lifecycle.
- Participate in and provide regulatory input to project teams to ensure that international product registrations and licensing applications (original submission and subsequent product enhancements) meeting regulatory requirements.
- Compile, prepare, and review documentation for regulatory submissions worldwide, license renewals, and product/manufacturing changes (US and international).
- Review and advise on product labeling, product claims, and other publications to ensure compliance with regulations.
- Review and approve technical documentation in compliance with regulatory requirements.
- Participate as the regulatory core functional product team member for the organization’s Clinical Chemistry regulatory team.
- Assist in SOP development and review. Provide regulatory input to product lifecycle planning.
- Determine and communicate submission and approval requirements to the core
- functional product team.
- Participate in risk benefit analysis for regulatory compliance.
- Monitor impact of changing regulations on submission strategies.
- Monitor applications/submissions under regulatory review. Communicate timelines and review status to the core functional product team.
- Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions and shares ideas freely.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s degree (or equivalent)
- 3-4 years’ experience in a regulated industry (e.g., medical products, devices). Note: Higher education may compensate for years of experience.
- Bachelor's degree in science (biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy/pharmacology), math, engineering, or another medically related field.
- Advanced degree in a technical area is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- 2-5 years of experience in regulatory but may consider quality assurance, research and development/support, scientific affairs, operations, or related technical area.
- Regulatory knowledge in standards, guidance's, policies, and regulations.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.