Regulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The company has a portfolio of life-changing technologies that spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. The company is looking for a Regulatory Affairs Manager – International Compliance Operations to work on-site at their Alameda, CA location in the Diabetes Care Division.

Requirements

• Bachelor's degree or an equivalent combination of education and work experience
• Minimum 8 years' experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices
• Ability to work effectively on project teams
• Strong organizational skills with the ability to juggle multiple and competing priorities
• Scientific writing experience is required
• Working knowledge of QSR, ISO, and EN standards
• Strong working knowledge of regulatory requirements for European community, Japan, Canada, and other countries
• Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• Freedom 2 Save student debt program
• FreeU education benefit
• Career development with an international company where you can grow the career you dream of