Regulatory Affairs Manager – APAC

About Abbott

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 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 position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislation in the APAC region. You will be responsible for managing a small 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.

What You'll Work On

• Managing 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 or IVD submissions to regulatory agencies in the APAC region
• 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
• 4-5 years' experience in a regulated industry (e.g., medical products, nutritionals)
• 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
• Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization

Preferred Qualifications

• Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields
• Masters in technical area or MBA; PhD in a technical area or law
• 5+ years' experience in regulatory affairs
• Supervisory experience
• Scientific writing experience
• 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)

Job Details

• Job Family: Regulatory Operations
• Division: ADC Diabetes Care
• Location: United States > Alameda: 1360-1380 South Loop Road
• Work Shift: Standard
• Travel: Yes, 20% of the time
• Medical Surveillance: No
• Base Pay: $114,000.00 – $228,000.00

Significant Work Activities

• Awkward/forceful/repetitive (arms above shoulder, bent wrists)
• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Equal Opportunity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

• EEO is the Law link
• English: http://webstorage.abbott.com/common/External/EEO_English.pdf
• EEO is the Law link
• Español: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf