About this role
Job title: Regulatory Affairs Manager – APAC
About the Role Abbott is seeking a Regulatory Affairs Manager – APAC who will work on-site in Alameda, CA, focused on the Diabetes Care product portfolio. You will collaborate with in-country regulatory representatives across APAC to ensure compliant business processes and timely registrations, and you will help develop robust global regulatory strategies while leading a small regulatory team to support submissions and data presentation for APAC product registrations.
What You'll Do
- Manage a team of regulatory specialists.
- Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care’s projects.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Work closely with in-country regulatory representatives, compile, prepare, and review medical device submissions for APAC registrations.
What We're Looking For
- Experience in managing a team of regulatory specialists and coordinating regulatory activities across APAC.
- Ability to develop and implement regulatory strategies and provide technical guidance on regulatory requirements for Diabetes Care projects.
- Strong collaboration with in-country regulatory representatives and cross-functional teams to support medical device submissions.
- Demonstrated ability to navigate complex regulatory issues and articulate strategies for global regulatory compliance.
Compensation & Benefits
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
- A company recognized as a great place to work in dozens of countries and consistently noted for diversity and leadership.