Quality And Regulatory Affairs Specialist

Quality and Regulatory Affairs SpecialistAt 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 doQuality Assurance (QA)Handle and manage local annual GDPMDS and GDP inspection; support inspection readinessMaintain and manage all controls of documents and recordsManage 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, etcManage new and existing supplier management activitiesPerform personnel training to ensure regulatory and quality complianceRegulatory Affairs & Pharmacovigilance (RA & PV)Manage and process AE intake for all productsManage compliance of all PV SOPsProvide regulatory support in RA activitiesYou are someone whoHolds a Bachelor's degree in Life Sciences, Pharmacy, or a related disciplineHas at least 2 years of experience in pharmaceutical or medical device QA or RA, with some exposure to PVIs familiar with Singapore HSA regulations, including Health Supplements Guidelines, Medical Device Regulations, and GDPHas experience in SOP writing, inspection preparation, and Quality Management Systems (QMS)Demonstrates strong documentation, regulatory filing, and communication skillsIs eager to grow with the company and open to cross-functional learning and developmentIs ready to take on more responsibilities within the Quality & Regulatory Affairs domain; training and mentorship providedIs adaptable and willing to support the team with ad hoc tasks when required.It's a bonus if you also haveKnowledge or exposure to US FDA biologic regulations and pharmacovigilance systemsExperience in SME distribution companies or startup environmentsExperience in preparing for inspection readinessWhat we offerCompetitive salary and performance-based bonusesOpportunities for professional growth and developmentCoffee treats from our generous bossesA team of hard-working colleagues who work hard and play hard

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