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

About the role

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.

Responsibilities

• Manage a team of regulatory specialists
• Develop and advance the organization's 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

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

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 are 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)

Skills

• Knowledge of regulatory requirements for the APAC region
• Technical regulatory skills
• Strategic input and technical guidance on regulatory requirements
• Ability to anticipate regulatory and related obstacles

Benefits

• Health Investment Plan (HIP) PPO medical plan
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• Recognition as a great place to work in dozens of countries around the world
• Nominated as one of the most admired companies in the world by Fortune
• 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

Pay

The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.

Schedule

Not specified

Application Instructions

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