APAC Regulatory Strategy Lead – Medical Devices

Abbott; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical HIP PPO coverage

Tuition reimbursement

Freedom 2 Save student debt program

FreeU education benefit

High employer contributions retirement

Job summary

Abbott in Alameda, CA seeks a Regulatory Affairs Manager – APAC to lead a small regulatory team and shape global regulatory strategies for Diabetes Care in the APAC region. You will coordinate with local regulators, prepare submissions, and ensure compliance across product lifecycles.

The role requires experience in regulated industries and strong communication skills, with the ability to guide cross-functional teams through complex regulatory issues across multiple markets.

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.

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.

Skills

Verbal and written communications

Education

Bachelor's Degree or equivalent

Job description

Abbott in Alameda, CA seeks a Regulatory Affairs Manager – APAC to lead a small regulatory team and shape global regulatory strategies for Diabetes Care in the APAC region. You will coordinate with local regulators, prepare submissions, and ensure compliance across product lifecycles.

The role requires experience in regulated industries and strong communication skills, with the ability to guide cross-functional teams through complex regulatory issues across multiple markets.