Regulatory and Quality Affairs Lead

I'm supporting a fast-growing Healthtech startup driving innovation in the medical device space. You'll lead the regulatory and quality strategy across US and APAC markets, ensuring compliance, accelerating product approvals, and embedding a strong culture of quality across the organization. Key Responsibilities Oversee the ISO 13485 Quality Management...

I'm supporting a fast-growing Healthtech startup driving innovation in the medical device space. You'll lead the regulatory and quality strategy across APAC markets, ensuring compliance, accelerating product approvals, and embedding a strong culture of quality across the organization. Key Responsibilities Oversee the ISO 13485 Quality Management System to...

I'm supporting a fast-growing Healthtech startup driving innovation in the medical device space. You’ll lead the regulatory and quality strategy across US and APAC markets, ensuring compliance, accelerating product approvals, and embedding a strong culture of quality across the organization. Key Responsibilities Oversee the ISO 13485 Quality Management...

**Responsibilities**: - Obtain timely renewal of product licenses and maintain registration database - Ensure appropriate licensing, regulatory, marketing and legal compliance of products in each country with the support of local regulatory/distribution partner - Liaise with regulatory bodies and distribution partners in the region to maintain product...

About Us Vivo Surgical is Southeast Asia’s pioneering surgical technology disruptor, engaged in developing innovative medical device solutions for better surgeries. An ISO 13485 certified company with international accreditations such as the US FDA and EU CE Mark, our products target the medical needs of the world through innovative Our technologies...

At Majeton, weare driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality & Regulatory Affairs...

**Specific duties include but are not limited to**: - Lead and manage a team of regulatory and quality professionals, fostering a culture of excellence, collaboration, and continuous improvement including: creating regulatory strategies, preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to...

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.Regulatory Affairs & QMS Manager.Reporting to the Chief QARA Officer (Based in Singapore), you will be...

Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...

Principal Regulatory Affairs and Quality Specialist - AGM **Job no**: 615794 **Work type**: Permanent **Location**: Singapore **Categories**: Quality & Regulatory, Individual Contributor **Cochlear’s** mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our...