Senior Regulatory Affairs Specialist, APAC
4 weeks ago
As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of APAC Sourced Finished Medical Devices (SFMD) projects and integrations with relevant regulations. You will be responsible for developing and implementing regulatory strategies, researching and monitoring regulatory requirements, and collaborating with internal and external stakeholders to achieve business objectives.
Key Responsibilities- Provide regulatory expertise and guidance to APAC SFMD project teams and Integration teams
- Collaborate with teams to guide the regulatory requirements and expectations for compliant submissions and approvals
- Develop and implement regulatory strategies for new APAC SFMD products and integrations
- Research and 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 and timely support for projects
- Manage sustaining activities associated with APAC SFMD, including change assessments and distribution controls
- Act 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
- 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
- Effective research, analytical, and problem-solving skills
- Excellent written and oral communication and technical writing skills
- Quick learner, self-motivated, and independent worker with minimal supervision
- Ability to establish a wide range of business relationships
- Team player with excellent interpersonal skills
As a leader in medical science for over 40 years, Boston Scientific is committed to solving the challenges that matter most. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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