Quality and Regulatory Affairs Specialist
16 hours ago
Roles & Responsibilities At Majeton, we are 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 Tell employers what skills you have CAPAFDARegulatory ComplianceQuality AssuranceQuality Management SystemsRegulatory AffairsMentorshipAdaptableWritingCommunication SkillsVigilanceRegulatory RequirementsLife SciencesPharmacovigilanceManufacturingAudit
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Quality and Regulatory Affairs Specialist
1 week ago
Singapore MAJETON PTE. LTD. Full timeAt 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...
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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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Regulatory Affairs Specialist
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Singapore Cochlear Ltd Full timePrincipal Regulatory Affairs and Quality Specialist - AGM **Job no**: 615794 **Work type**: Permanent **Location**: Singapore **Categories**: Quality & Regulatory, Individual Contributor **Cochlear’s** mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our...
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Specialist, Regulatory Affairs
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Singapore MSD Full time**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...
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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 Specialist
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Singapore Agilent Technologies, Inc. Full timeAs a Regulatory Affairs Specialist, you will develop and implement programs and processes and provide support to ensure that Agilent products are safe, legal, and meet or exceed customer expectations and quality in compliance with regulations, standards, company policies, and business objectives. You will perform activities which include: - Keeps abreast...
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Specialist, Regulatory Affairs
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Singapore ResMed Full time $80,000 - $120,000 per yearAbout ResMedAt ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and...
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Regulatory Affairs
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Central Singapore Emprego SG Full time**Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $5,000 - $10,000 Per Month **Date Posted** 6 minutes ago Additional Details **Job ID** 3010 **Job Views** 1 Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting multiple...
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Regulatory Affairs Specialist
1 week ago
Singapore Reeracoen Singapore Pte Ltd Full timeOur client is Medical medical devices company and now they are looking for Regulatory Affairs Specialist. You will be reporting to Regulatory Affairs Manager 【 What you will be doing 】 - Responding to company policy and company requirements, propose strategic regulatory - Assess regulatory requirements and develop regulatory strategies for the...
