Regulatory Affairs Specialist II

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.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.An excellent retirement savings plan with high employer contribution.Tuition reimbursement and education benefits - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world.The OpportunityOur Toxicology business unit has an opportunity for a Regulatory Affairs Specialist II which can be based in either San Diego, CA or Pomona, CA. This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files.What You’ll Work OnProvides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations.Assists in developing regulatory strategies for new and modified products to achieve clearance/approval.Researches scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy.Assesses product, manufacturing, and labeling changes for regulatory impact and compliance.Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.Organizes and maintains department files and keeps informed of global regulatory information.Demonstrates commitment to the Company Quality Management System per ISO, FDA, and other regulatory agencies.Exhibits professional behavior with internal/external business associates, reflecting positively on the company.Understands the quality consequences of improper job performance and is aware of potential device defects in their area of responsibility.Required QualificationsBachelor's degree (BS/BA) in any biological science or technical degree.2-5 years experience in Regulatory Affairs with 1-3 years of progressively responsible positions.Preferred Qualifications1-3 years in an IVD or medical device manufacturing environment.Good knowledge of federal regulations.Good knowledge of product labeling and related requirements.Good knowledge of quality systems in a regulated manufacturing environment.Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio.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.The base pay for this position is $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.

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