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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 113,000 colleagues serve people in more than 160 countries.
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Abbott Rapid Diagnostics is hiring a SR. REGULATORY AFFAIRS SPECIALIST and can be based in either LAKE FOREST, IL or POMONA, CA. This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies. Remote work may be considered based on candidate experience.
WHAT YOU’LL DO
- Provides regulatory support for commercial diagnostic products
- Develops regulatory strategies to achieve clearance/approval internationally (outside United States)
- Compiles and publishes all material required for submissions, license renewals, and annual registrations
- Works with governmental regulatory agencies and other third-party accrediting bodies
- Maintains approvals/licenses/authorizations for existing marketing authorizations
- Adds and maintains information contained in the Global Regulatory Information Database
- Provides recommendations on labeling, for regulatory compliance
- Develops internal procedures and tools
- Conducts informational or training sessions for stakeholders
- Organizes and maintains hard copy and electronic department files
- Keeps informed of global regulatory information
- Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s degree (BS/BA) in a scientific field
- 3-5 years of experience in a regulated industry
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
- Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
- Must be detail-orientated, self-motivated and available for flexible scheduling
- Strong written and verbal communication, problem solving and motivational skills
- Remote may be considered based on candidate experience
- MDR/IVDR/technical file experience or 510(k) experience
- 3 years of experience in Regulatory Affairs
- Three plus years in an IVD or medical device manufacturing environment
- 510k submission experience
- Technical file creation and maintenance experience
- Strong knowledge of US and Foreign regulations
- Able to work on multiple tasks simultaneously as a team member and/or ability to operate as an individual contributor
- Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling
- Remote work may be considered based on candidate experience
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: http://www.abbottbenefits.com/pages/candidate.aspx
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.
Learn more here
Job posted: 2022-07-10