Assistant Regulatory Affairs Manager
10 hours ago
Job Description 1. Maintain Quality Management System, Certification and Registration in compliance to regulatory requirement (ISO9001, ISO13485, US FDA, cGMP) Product registration in US, UK, Japan, Singapore, and other countries Environmental control, monitoring and reporting, not limited to cleanroom air/surface microbial, temperature & humidity, particle count, product bioburden, 3rd party certification, PEST control, LAL testing. Manages failure investigations, including customer complaints and non-conforming events, and implementation of effective preventive and corrective actions. Manages sterilization, transportation, stability, biocompatibility, and product release activities Maintain current regulatory affairs and technical knowledge and perform gap analysis and QMS system implementation and training to staff for compliance Maintain library of product and process-related reference standards, regulations, guidance's, clinical articles. Guidance in risk management review & approval, develop risk management strategies & approaches. Report FDA advisory notice and MDR Lead 8S program and maintain good 5S housekeeping and safety at workplace Drive Operational Excellence program in continiuos improvement Perform any other duties as assigned from time to time Job Requirement Minimum 3 years experience in either domestic and regional regulatory affairs in medical device industry, preferably molding industry. Familiar in QC Tools, FMEA, SPC, Poka Yoke Knowledge in Sterilization, Micro-lab, bioburden and endotoxins test will be added advantage Certified Internal Auditor, 6 sigma trained Team player Good communication skills Good analytical and problem solving skills Good eyesight, Proficient in English and Chinese, both veral and written #J-18808-Ljbffr
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Regulatory Affairs Manager
4 days ago
Singapore Align Technology Full time**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...
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Regulatory Affairs Associate
4 days ago
Singapore PRESTIGE BIOPHARMA LIMITED Full time**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...
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Regulatory Affairs Intern
2 weeks ago
Singapore GE HEALTHCARE Full time**Job Description Summary**: We are seeking a detail-oriented and motivated intern to support the Regulatory Affairs team with UDI (Unique Device Identification) data entry activities for Australia and Singapore. This role is ideal for students or recent graduates interested in regulatory affairs, data management, or the medical device industry. **Key...
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Manager, Regulatory Affairs Apac
1 week ago
Singapore Johnson & Johnson Full time**Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Hong Kong, Hong Kong, Hsinchu City, Hsinchu County, Taiwan, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Singapore, Singapore **Johnson & Johnson is currently seeking a Manager,...
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Regulatory Affairs Associate Manager
1 week ago
Singapore Johnson & Johnson Full timeAt 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...
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Regulatory Affairs Intern
1 week ago
Singapore GE HealthCare Full time $40,000 - $60,000 per yearJob Description SummaryWe are seeking a detail-oriented and motivated intern to support the Regulatory Affairs team with UDI (Unique Device Identification) data entry activities for Australia and Singapore. This role is ideal for students or recent graduates interested in regulatory affairs, data management, or the medical device industry.Job DescriptionKey...
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Regulatory Affairs Specialist
1 week ago
Singapore Johnson & Johnson Full timeJohnson & 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...
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Regulatory Affairs Executive
2 weeks ago
Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full timeFull 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; - Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations; - Have working knowledge...
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Regulatory Affairs Project Manager
2 weeks ago
Singapore REGASK PTE. LTD. Full time**OUR COMPANY RegASK is an international, diverse and rewarding place to work. If you are a builder, highly autonomous in your working style, and eager to problem solve, we would love to hear from you. **THE POSITION **_Title: _**Regulatory Affairs Project Manager RegASK is a digital platform, using artificial intelligence for augmenting regulatory...
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Regulatory Affairs Director
1 week ago
Singapore Solventum Full time**3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the...