Deskripsi Pekerjaan
Are you an experienced Regulatory Affairs professional looking to make a meaningful impact on the future of healthcare? SingHealth, Singapore's largest public healthcare cluster, is seeking a strategic and detail-oriented Assistant Director to join our Medical Technology Office. In this pivotal role, you will be at the forefront of healthcare innovation, navigating the complex regulatory landscape to ensure that cutting-edge medical technologies are brought to market safely and efficiently.
As the Assistant Director (Regulatory Affairs), you will serve as a key liaison between clinical innovators, engineering teams, and regulatory bodies. You will lead efforts in formulating regulatory strategies, managing compliance processes, and ensuring that our technological advancements meet the rigorous standards required by the Health Sciences Authority (HSA) and other relevant international agencies. This is a unique opportunity to work within a dynamic, multidisciplinary environment where your work directly contributes to improving patient outcomes across Singapore.
Tanggung Jawab
- Develop and execute comprehensive regulatory strategies for new medical technology projects and research initiatives.
- Lead submissions for device registration, clinical trial authorizations, and license applications with the Health Sciences Authority (HSA).
- Collaborate with internal stakeholders and cross-functional teams to ensure regulatory compliance throughout the product development lifecycle.
- Interpret and advise on international regulatory requirements (e.g., FDA, CE Marking) to support global technology adoption.
- Manage relationships with regulatory authorities and external partners to facilitate smooth approval processes.
- Conduct internal audits and risk assessments to maintain high standards of quality and regulatory adherence.
- Provide expert guidance to clinical innovators regarding regulatory pathways, quality systems, and documentation standards.
Kualifikasi
- Bachelor’s degree in Biomedical Engineering, Life Sciences, Pharmacy, or a related healthcare discipline.
- Minimum of 6-8 years of experience in regulatory affairs, specifically within the medical device or MedTech industry.
- In-depth knowledge of Singapore’s Health Products Act and HSA regulatory framework.
- Proven track record of successful regulatory submissions and interactions with government health authorities.
- Strong project management skills with the ability to handle multiple complex innovation projects simultaneously.
- Excellent communication and interpersonal skills to engage effectively with clinical professionals and technical staff.
- Experience with ISO 13485 quality management systems is highly desirable.