Regulatory Affairs Manager – APAC - Diabetes Care (on-site)

Abbott • Alameda, CA

303d • $112,000 - $224,000

About The Position

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 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. 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.

Requirements

• 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

Nice To Haves

• 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)

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree