Sr. Regulatory Affairs Specialist (31023563)
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.
Our location in Lake Forest, IL or Pomona, CA currently has an opportunity for a Sr. Regulatory Affairs Specialist. 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: [Register to View]
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.