Senior APAC Regulatory Affairs Strategist

Intuitive; Malaysia; Sur place; MYR 90 000 - 130 000; Plein temps

Résumé du poste

Intuitive seeks a Regulatory Affairs professional to lead regulatory strategy for medical device registrations in APAC indirect markets. The role coordinates with Distributor RA to assemble regulatory documentation, maintain licenses and manage change control while ensuring compliance with evolving regulations.

Experience with ISO13485 and related quality systems is preferred. Strong communication and teamwork across BU RAs, Commercial, and PMO are essential to support business objectives.

Qualifications

• Bachelor's degree in Medical Technology, Life Sciences, Pharma or similar sciences.
• Knowledge of ISO13485, GDPMDS or similar quality management system requirements and broad understanding of what it takes to work in a regulated environment.

Responsabilités

• Execute regulatory plans for medical device registrations in APAC indirect markets.
• Coordinate with Distributor RAs and Intuitive stakeholders to ensure compliance with medical device regulations in APAC indirect markets.
• Determine types of regulatory submissions or internal documentation required during new product submissions, changes, notifications, etc.
• Input and manage regulatory submission tracking information in Intuitive's regulatory databases.
• Compile high quality submissions meeting technical requirements from regulatory authorities.
• Perform periodic regulatory surveillance and impact assessments using TrackWise.
• Support other teams in ensuring regulatory compliance as required.
• Perform other tasks as assigned.

Formation

Bachelor's degree in Medical Technology, Life Sciences, Pharma or similar sciences

Description du poste

Intuitive seeks a Regulatory Affairs professional to lead regulatory strategy for medical device registrations in APAC indirect markets. The role coordinates with Distributor RA to assemble regulatory documentation, maintain licenses and manage change control while ensuring compliance with evolving regulations.

Experience with ISO13485 and related quality systems is preferred. Strong communication and teamwork across BU RAs, Commercial, and PMO are essential to support business objectives.