Regulatory affairs coordinator
2 months ago
Regulatory Affairs Coordinator Location: Singapore, Singapore Time Type: Full time Posted on: 5 Days Ago Job Requisition ID: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of regulatory documents, maintaining records, and coordinating with various departments to support product registrations and regulatory submissions. Responsibilities and Accountability: Regulatory Submissions: Assist in the preparation of regulatory documentation for product registrations, amendments, and renewals in compliance with global regulatory requirements. Document Management: Maintain up-to-date regulatory documents and ensure proper organization, tracking, and archival of submission dossiers, technical files, and other regulatory records. Communication & Coordination: Collaborate within the RA departments to gather necessary information for regulatory submissions and maintain clear communication with regulatory agencies. Post Market Surveillance Support: Assist in coordinating post market activities such as adverse event reporting, field actions, and periodic safety updates in accordance with applicable regulations. Regulatory Database Management: Update and maintain databases related to regulatory submissions, approvals, and compliance tracking. Audits & Inspections: Provide support during regulatory audits and inspections, helping to prepare and organize necessary documents and reports. Training & Documentation: Assist in developing and updating training materials on regulatory processes, ensuring company-wide awareness of compliance obligations. Job Environment: Res Med’s products must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. This includes, but is not limited to, the Food and Drug Administration (FDA) in the United States of America, the relevant competent authorities in Europe, and the Therapeutic Goods Administration (TGA) in Australia, as well as applicable international standards such as ISO 13485. The QA and RA Departments located at various operating units around the world are required to ensure that management systems are established to enable Res Med to comply with, and be able to readily display their compliance with, multiple regulatory frameworks and to support the design, development, and manufacture of products which meet our customer’s quality requirements. Qualifications and Experience: Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field. 1-3 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or biotech industries. Familiarity with global regulatory requirements (e.g., FDA, EMA, Health Canada, TGA, etc.). Proficient in regulatory submission processes, document management systems, and quality systems. Strong organizational skills and attention to detail. Excellent verbal and written communication skills. Ability to work both independently and collaboratively in a fast-paced environment. Proficiency in Microsoft Office (Word, Excel, Power Point). Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive, and inspiring. Where a culture driven by excellence helps you not only meet your goals but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now #J-18808-Ljbffr
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Regulatory affairs coordinator
2 months ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Apply to locations: Singapore, Singapore Time type: Full time Posted on: 6 Days Ago Job requisition id: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the...
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ResMed Inc | Regulatory Affairs Coordinator
3 weeks ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Location: Singapore, Singapore Time Type: Full time Posted on: 5 Days Ago Job Requisition ID: JR_035534The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of...
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ResMed Inc | Regulatory Affairs Coordinator
3 days ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Apply to locations: Singapore, Singapore Time type: Full time Posted on: 6 Days Ago Job requisition id: JR_035534The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the...
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Associate, Regulatory Affairs
2 months ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeRoles & ResponsibilitiesAbout APACMedFounded 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...
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Regulatory Affairs Specialist
4 weeks ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeAbout UsAsia Pacific Medical Technology Association Ltd. is a leading advocate for the medical technology industry in the Asia-Pacific region.We are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join our dynamic team.Job SummaryThe successful candidate will be responsible for monitoring regulatory developments across APAC,...
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Singapore PSA International Full timeJob Title: Regulatory Affairs Specialist The company is a fast-growing food and beverages business with a strong presence across Asia. Key Responsibilities: Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations. Stay up-to-date on changes in regulatory requirements and translate them into actionable steps...
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4 weeks ago
Singapore NYPRAX PHARMA PTE. LTD. Full timeOverviewNyprax Pharma Pte. Ltd., a rapidly expanding Regulatory Affairs Consultancy firm, seeks a skilled Regulatory Assistant to join our team.
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Project manager, regulatory affairs
1 month ago
Singapore PRESTIGE BIOPHARMA LTD Full timeJOB FUNCTION Project Manager, Regulatory Affairs MAIN RESPONSIBILITIES Manage project submissions as assigned by Regulatory Affairs leadership Support the management of key projects, including execution, for submission, approval, and launch Review, prepare and author documents for regulatory submissions including clinical trial applications, marketing...
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4 weeks ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeJob Title: Regulatory Affairs SpecialistThe company is a fast-growing food and beverages business with a strong presence across Asia.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations.Stay up-to-date on changes in regulatory requirements and translate them into actionable steps for...
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4 weeks ago
Singapore RANDSTAD PTE. LIMITED Full timeAbout RANDSTAD PTE. LIMITEDOur client is a world-class MNC Healthcare company, specializing in Innovative Medicine and MedTech. They empower themselves to tackle global health challenges through innovation and technology, ultimately transforming patient care.SalaryThe estimated salary range for this role is SGD $60,000 - SGD $80,000 per annum, depending on...
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Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full timeRoles & ResponsibilitiesJob Description Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings; Communicate changes and new requirements to management; Request and submit documents for product registration and amendments applications;...
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Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full timeRoles & ResponsibilitiesJob Description Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings; Communicate changes and new requirements to management; Request and submit documents for product registration and amendments applications;...
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4 weeks ago
Singapore PRESTIGE BIOPHARMA LIMITED Full timePrestige Biopharma Limited is seeking an experienced Regulatory Affairs Project Lead to join our team.About the RoleWe are looking for a highly skilled and motivated individual to lead regulatory affairs projects from submission to approval, ensuring timely delivery and quality results.The successful candidate will have at least 3-5 years of experience in...
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Project Manager, Regulatory Affairs
3 weeks ago
Singapore PRESTIGE BIOPHARMA LIMITED Full timeRoles & ResponsibilitiesJOB FUNCTIONProject Manager, Regulatory AffairsMAIN RESPONSIBILITIES· Manage project submissions as assigned by Regulatory Affairs leadership· Support the management of key projects, including execution, for submission, approval, and launch· Review, prepare and author documents for regulatory submissions including clinical trial...