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Urgent! Quality and Regulatory Affairs Specialist Job Opening In Singapore, Singapore – Now Hiring Majeton Pte. Ltd.

Quality and Regulatory Affairs Specialist



Job description

Overview
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.


Responsibilities
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
Qualifications
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.


Nice to 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


Required Skill Profession

Other General



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