Regulatory Affairs Specialist Ii – Apac - Diabetes Care

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 Abbott

At 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, the Freedom 2 Save student debt program and FreeU education benefit - 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 and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This Regulatory Affairs Specialist II - APAC will work out of our Alameda, CA, location in the Diabetes Division.

The person hired in this role will be responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory direction on team activities. Applies basic regulatory understanding to support of product and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support. Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

What You’ll Work On

• Responsible for regulatory activities of APAC countries to launch and secure the products in the markets.
• Basic understanding of laws and regulations of the responsible APAC countries.
• Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, and project plans.
• Works with supervisory input for interpretation, leading to the solution of issues and product development and support.
• Advises project groups on preliminary or fully assessed regulatory strategies and Implements Division Regulatory Strategy in specific product-related activities.
• Provides input regarding regulatory areas to establish group plans and implementation of those plans.
• Establishes and executes against project goals and implements plans.
• Prepares and aligns impact goals with department goals.
• Directs own daily activities by utilizing team goals and division regulatory priorities.
• Provides support to Regulatory Affairs management when working towards resolution of compliance issues, assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
• Analyzes the input of cumulative product changes to current product submissions.
• Provides solutions to various problems where analysis requires moderate evaluation.
• Supports APAC affiliate RA's essential negotiations on routine product-related issues with government agencies.
• Obtains supervisory regulatory review on submission documents before submission to government agencies.
• Signs off at the team level within delegated parameters for change control.
• Releases authority for labeling/sales/promotional materials.
• Shares knowledge with others in the department and on teams.
• Follows GMP guidelines and procedures.

Required Qualifications

• Bachelor's Degree, preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc., an equivalent combination of education and work experience
• Minimum 5 years of experience

Preferred Qualifications

• Experience working with Medical Devices.
• Desire 1-2 years of regulatory experience.
• Experience working with software devices
• Ability to communicate both orally and in writing in Chinese and/or Japanese.
• RAPS Certification.

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $73,600.00 – $147,200.00. In specific locations, the pay range may vary from the range posted.