Regulatory Affairs

This is a full-time hybrid role as a Regulatory Affairs Manager at Artixio. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining quality systems. The role is based in Singapore but allows for some remote work. **Qualifications** - Minimum...

**Job Description & Requirements** Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation. **Responsibilities** - Support regulatory assessment of submission requirements based on relevant regulations - Assist with administrative work necessary 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...

**Alcotech Pte Ltd**specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. **Role Overview**: **Key Responsibilities**: - Prepare, review, and submit medical device registration dossiers...

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...

**PURPOSE OF JOB** Subject matter expert in determining the current regulatory requirements and strategies for Merit Medical Singapore design control projects. Prepare documents and /or submission required to obtain clearance or approval from government agencies for commercial distribution of Merit’s Medical Devices. Key government agencies with direct...

Regulatory Affairs Director **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:Singapore, Singapore, SG **About the department** - You will join our Regulatory Affairs team in Region APAC, based in Singapore. Our team is responsible for ensuring regulatory compliance for new products and product amendments, thereby keeping our license to...

**Description**: **Join a team that is changing millions of lives.** Transforming smiles. Transforming lives. Transforming an industry. At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the...

**Duties**: - Manage renewal processes of medical device for maintaining regulatory compliance - Facilitate the dissemination of documentation (eg. Letter of Authorization, Free Sales Certificates, Certificates of Origin, etc) to both internal and external parties - Serve as internal consultant for basic regulatory affairs support involving issues such as...

This position has responsibility for Regulatory Affairs within Malaysia, Singapore and Brunei. This includes: Support regulatory affairs team on other regulatory affairs matters especially those which are required from personnel based in Singapore.Ensure minimal supply disruption from regulatory affairs scopes.Ensure required licenses are maintained and...