Regulatory Affairs Manager

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...

At RESPIREE PTE. LTD., we are seeking a highly skilled Regulatory Affairs Manager to oversee regulatory compliance and quality assurance functions within our organization. This is an exciting opportunity for a seasoned professional with expertise in the medical device industry.Key ResponsibilitiesPrepare high-quality technical documentation.Manage regulatory...

Roles & ResponsibilitiesRegulatory Affairs and Quality Assurance InternWe're seeking a detail-oriented and organized individual to support our Regulatory Affairs and Quality Assurance (RAQA) team.We are looking for an intern who can begin in Apr/May 2025, and can commit for at least 3 months.Key Responsibilities- Maintain and update regulatory documentation...

Roles & ResponsibilitiesRoles & ResponsibilitiesThe RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and...

At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for...

**About APACMed** Founded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully committed to facilitating...

APAC regulatory affairs - Pharmaceutical industry - Singapore registered pharmacist Reporting to the Head of Regulatory Affairs, you will be responsible for assimilating knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. You will provide strategic...

**Responsibilities**: - Lead and supervise the SG Regulatory Affairs (RA) - Accountable for all Products Registration, renewals, and amendments - Communicate with regulatory authorities as well as regional RA team regarding regulatory affairs matters such as product registrations, changes in existing products and renewals. - Advise internal stakeholders on...

Develop and implement regulatory strategies to secure product approvals more quickly than competitors. - Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment. - Provide expert advice on regulatory strategy, Health Authority engagement, and submission activities for the IVD product lines. -...

**Regulatory Affairs Manager, SEA** **YOUR TASKS AND RESPONSIBILITIES**: The Regulatory Affairs Manager is responsible for managing Environmental Science South East Asia (SEA) region registration. The main countries include Malaysia, Indonesia, Singapore as well as providing support the registration process for Philippines, Taiwan and Hong Kong. The role...

**Your new company** Join one of the leading pharmaceutical company today! Excellent opportunities for learning in Regulatory Affairs work. **Your new role** - Communicate with regulatory authorities as well as overseas counterparts with regards to regulatory affairs matters such as product registrations, changes in existing products and renewals - Ensures...

**Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...

The Head of Regulatory Affairs will be responsible for ensuring that our company complies with all relevant regulations and laws. This role requires a deep understanding of the pharmaceutical industry's regulatory environment and involves developing regulatory strategies, overseeing regulatory submissions, and liaising with regulatory bodies. Job...

**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...

**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...

The Regulatory Affairs Assistant Manager will be responsible for leading and managing Security Trade Control (Export Control) for the SEA Region.Key responsibilities include:Leading and managing Security Trade Control (Export Control)Overseeing security trade control operations across the companyManaging notifications and verifications for the end-user...

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...

**Regional Regulatory Affairs Manager (Product Stewardship)** - Permanent Job Opportunity - Regional scope - APAC including Japan, Korea and China - High Visibility role - Key Focal Point of Contact for Product Stewardship & Regulatory Affairs matters in APAC region - Managing the Product Regulatory requirements and compliance guidelines across APAC...

Cosmostar Singapore Private Limited requires a highly skilled Regulatory Affairs Officer to manage our regulatory affairs effectively. In this role, you will be responsible for ensuring compliance with external regulations and internal standards.Key Responsibilities:Review and revise contracts to ensure compliance with external regulations and internal...

**Specialist, Regulatory Affairs** **THE OPPORTUNITY** - Based in Singapore, top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021). - Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our...