Quality and Regulatory Affairs Specialist
5 hours ago
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 Specialist to join our team and ensure regulatory compliance, uphold product quality, and oversee vigilance reporting for all of our marketed products. What you will do: Quality Assurance (QA)Handle and manage local annual GDPMDS and GDP inspection; support inspection readiness Maintain and manage all controls of documents and records Manage and maintain local GDPMDS and GDP SOP and system records, including but not limited to all product complaints, returns, disposal, internal inspection/ audit, deviation,CAPA management, etc Manage new and existing supplier management activities Perform personnel training to ensure regulatory and quality compliance Regulatory Affairs & Pharmacovigilance (RA & PV)Manage and process AE intake for all products Perform signal detection Manage compliance of all PV SOPs Provide regulatory support in RA activities You are someone who: Holds a Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline Has at least 2 years of experience in pharmaceutical or medical device QA or RA, with some exposure to PV Is familiar with Singapore HSA regulations, including Health Supplements Guidelines, Medical Device Regulations, and GDP Has experience in SOP writing, inspection preparation, and Quality Management Systems (QMS)Demonstrates strong documentation, regulatory filing, and communication skills Is eager to grow with the company and open to cross-functional learning and development Is ready to take on more responsibilities within the Quality & Regulatory Affairs domain; training and mentorship provided Is adaptable and willing to support the team with ad hoc tasks when required. It’s a bonus if you also have: Knowledge or exposure to US FDA biologic regulations and pharmacovigilance systems Experience in SME distribution companies or startup environments Experience in preparing for inspection readiness What we offer: Competitive salary and performance-based bonuses Opportunities for professional growth and development Coffee treats from our generous bosses A team of hard-working colleagues who work hard and play hard #J-18808-Ljbffr
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Regulatory Affairs Specialist
1 week ago
Singapore Ethos BeathChapman Full time**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...
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Regulatory Affairs Specialist
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Singapore Reeracoen Singapore Pte Ltd Full timeOverview Job title: Regulatory Affairs Specialist. Reference ID: 36639. Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and...
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Regulatory Affairs Specialist
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Singapore Poli Medical Company Pte Ltd Full timeCompany Description Poli Medical Company Pte Ltd, founded in 1971, began as a patent medicine manufacturer specializing in chinese pharmaceuticals and health supplements. Over the years, it has expanded to offer contract manufacturing/OEM services of private label health and food/health supplements and marketing/distribution of related products. Today, Poli...
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Regulatory Affairs Specialist
5 hours ago
Singapore Poli Medical Company Pte Ltd Full timeCompany Description Poli Medical Company Pte Ltd, founded in 1971, began as a patent medicine manufacturer specializing in chinese pharmaceuticals and health supplements. Over the years, it has expanded to offer contract manufacturing/OEM services of private label health and food/health supplements and marketing/distribution of related products. Today, Poli...
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Regulatory Affairs Specialist
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Singapore Johnson & Johnson Full timeCaring 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...
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Specialist, Regulatory Affairs
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Specialist, Regulatory Affairs
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Singapore Resmed Full timePosition Specialist, Regulatory Product Strategy & Delivery – Singapore (Regulatory Affairs)Overview Regulatory Affairs at ResMed is central to ensuring timely and compliant access to global markets. The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer, supporting New Product...
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Regulatory Affairs
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West Singapore Emprego SG Full time**Location** - Singapore, West**Job Type** - Permanent**Salary** - $3,500 - $8,000 Per Month**Date Posted** - 59 minutes agoAdditional Details **Job ID** - 97191**Job Views** - 6Roles & Responsibilities We are a global leader in the manufacturing of medical devices and delivering solutions to improve lives through today’s technology and future...
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AVP / VP of Regulatory and Quality Affairs
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Singapore Respiree Full timeAVP / VP of Regulatory and Quality Affairs Overview AVP / VP of Regulatory and Quality Affairs role focusing on regulatory and quality strategy for APAC with responsibilities spanning regulatory submissions, quality management, and cross-functional leadership within medical device software/manufacturing context. Responsibilities Develop and execute the APAC...
