Quality and Regulatory Affairs Specialist

4 days ago

Singapore Majeton Pte. Ltd. Full time

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

  • Regulatory Affairs Specialist

    1 week ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

  • Regulatory Affairs Specialist

    1 week ago

    Singapore Johnson & Johnson Full time

    Johnson & 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...

  • Regulatory Affairs Specialist

    4 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Regulatory Affairs Specialist

    1 week ago

    Singapore ALCOTECH PTE. LTD. Full time $49,300 - $63,500 per year

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Surveillance Regulatory Affairs Officer

    4 weeks ago

    Singapore Marina Bay Sands Full time

    Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HEREBe part of our diverse and...

  • Quality System Regulatory Affairs Specialist APJ

    4 weeks ago

    Singapore Leica Microsystems Full time

    Overview Quality System Regulatory Affairs Specialist APJ Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher's 15+ operating companies, our work saves lives and we are united by a shared commitment to innovate for tangible impact....

  • Quality Management, Regulatory Affairs

    4 weeks ago

    Singapore KINEXCS PTE. LTD. Full time

    Roles & ResponsibilitiesKinexcs is a multidisciplinary digital health start-up at the forefront of a rapidly booming industry. It is a data-driven digital therapy platform & wearables company to enable and empower people for mobility and a better life. Kinexcs strives to enable personalised health and evidence-based recovery for musculoskeletal...

  • Quality Management, Regulatory Affairs

    6 days ago

    Singapore Kinexcs Pte Ltd Full time $120,000 - $180,000 per year

    Kinexcs is a multidisciplinary digital health start-up at the forefront of a rapidly booming industry. It is a data-driven digital therapy platform & wearables company to enable and empower people for mobility and a better life. Kinexcs strives to enable personalised health and evidence-based recovery for musculoskeletal patients.Website: KinexcsJob...

  • Quality System Regulatory Affairs Specialist APJ

    2 days ago

    Singapore Danaher Life Sciences Full time

    Overview Quality System Regulatory Affairs Specialist APJ role at Leica Microsystems, a Danaher operating company. The position is responsible for maintaining the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems Commercial Offices in the APJ region....

  • Quality System Regulatory Affairs Specialist APJ

    4 weeks ago

    Singapore Fcld Full time

    Overview Quality System Regulatory Affairs Specialist APJ at Leica Microsystems. The role is to maintain the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems Commercial Offices in the APJ region. This position reports to the Manager RA/QA Commercial...