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About the Role
We are looking for an experienced Senior Regulatory Affairs Manager within the APAC regions to spearhead the regulatory registration and compliance for our cutting-edge medical devices. In this role, you will be responsible for developing and executing regulatory strategies, managing clinical trials, preparing registration dossiers, and overseeing the entire registration process from start to finish. You will play a pivotal role in project management, ensuring all regulatory timelines are met while staying compliant with local and international medical device regulations. As part of your responsibilities, you will keep up to date with regulatory changes, interpret new regulations, and ensure their timely implementation. You will also provide training to internal teams on regulatory requirements and maintain strong relationships with relevant regulatory authorities and external partners to ensure successful product registration and compliance.
About Sinclair
Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.
Our Vision
Providing aesthetic excellence globally.
Our Mission
Driving the advancement of product quality and customer satisfaction, investing in innovation and people.
Our Values
- Act with Integrity
- Be results driven
- Embrace your winning spirit
- Stay ahead of the game
- One team, one goal
Key Responsibilities:
- Lead the registration of radiofrequency and laser aesthetic medical devices, including the creation and execution of registration strategies, type testing, clinical trials, and dossier preparation.
- Manage the full registration process, including communication with regulatory bodies, addressing any registration issues, and ensuring compliance.
- Oversee project registration management, including the creation of project plans and budgets, ensuring projects are completed within timelines.
- Monitor, analyze, and implement changes in medical device regulations to ensure compliance with the latest standards.
- Conduct internal training on regulatory updates and product standards to ensure all teams are aligned with compliance requirements.
- Act as the primary liaison with regulatory authorities and external organizations, including testing centers and consulting firms, to maintain strong working relationships.
Essential :
- Bachelor degree above, major in medical or engineer
- More than 4 years registration experiences in medical device industry.
- Be familiar with APAC regulations on medical devices
- Good in written and spoken English and Mandarín
