Purpose Statement
The purpose of this role is to provide regulatory expertise and leadership for APAC Sourced Finished Medical Devices (SFMD) projects and integrations of acquired companies, ensuring alignment with business objectives and compliance with relevant regulations. The role involves developing and implementing regulatory strategies, researching and monitoring regulatory requirements, collaborating with internal and external stakeholders, and managing sustaining activities for APAC SFMD products across the region.
Roles & Responsibilities
- Acts as a core member on APAC SFMD project teams and Integration teams, providing Regulatory Affairs guidance throughout the projects
- Collaborate with teams to guide the regulatory requirements and expectations for compliant submissions and approvals, including planning, technical background, and issue identification that may impact goals and timelines for SFMD and Integration projects
- Develops and implements regulatory strategies for new APAC SFMD products and integrations
- Research regulatory requirements for geographies across the region. Monitor emerging trends and integrate new requirements into projects and regional toolkits
- Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for projects
- Manage sustaining activities associated with APAC SFMD – including change assessments on SFMD product and manufacturing changes and distribution controls to ensure compliance with applicable regulations
- Acts as APAC RA representative, developing and maintaining positive relationships with APAC OEM third party suppliers
- Establish and maintain systems, processes and tools for the management of SFMD projects and Integrations across APAC. Continuously assess ways to improve
Requirements
- A minimum of 5 years’ experience in the medical device industry within a regulatory affairs role
- Working knowledge of international regulations for medical devices
- General understanding of product development process and design control
- Ability to manage several projects of varying scope and complexity simultaneously while adhering to time schedules
- Effective research, analytical, and problem-solving skills
- Excellent written and oral communication and technical writing skills. Ability to translate technical information into a clear message
- Quick learner, self-motivated, and independent worker with minimal supervision
- Ability to establish wide range of business relationships
- Team player with excellent interpersonal skills
