Job Description

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.
• 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 - 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 S enior Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

This Senior Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. You will be responsible for managing a team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. Additionally, you will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislation in the APAC region.

 

What You’ll Work On

• Recruits, coaches and develops organizational talent.
• Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
• 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.
• Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC region.
• Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
• Utilize technical regulatory skills to propose strategies on complex issues
• Provide strategic input and technical guidance on regulatory authority queries.
• Evaluate proposed design and manufacturing changes for regulatory impact and implement required regulatory actions.
• Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
• Ensure compliance with product post marketing approval requirements
• Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements.
• Provide regulatory support for internal and external audits.

Required Qualifications

• Bachelor's Degree OR an equivalent combination of education and experience.
• Minimum 9 years’ related work experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material resources within a department or unit.
• Monitors company-wide indicators such as market share and profitability.
• Monitors external environment in area of technical or professional responsibility.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
• Facilitates others' participation in the continuous improvement program.
• Investigates and solves problems that impact work processes and staff within or across units or departments.
• Develops and communicates a vision for the organizational unit assigned.

Preferred Qualifications

• Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields; Master’s degree.
• Submission / registration types and requirements
• Domestic and international regulatory guidelines, policies and regulations
• Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization.
• Analytical thinking with good problem-solving skills.
• Working knowledge of ISO and EN standards, as well as country-specific standards in the APAC region.
• Strong working knowledge of regulatory requirements for the APAC region. 
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). 

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

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 , on Facebook at and on Twitter @AbbottNews. Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $128,000.00 – $256,000.00. In specific locations, the pay range may vary from the range posted.

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