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Quality and Regulatory Affairs Specialist

Quality and Regulatory Affairs Specialist

MajetonQueenstown, Otago, New Zealand
30+ days ago
Job description

Quality and Regulatory Affairs Specialist

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
  • 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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    Quality Specialist • Queenstown, Otago, New Zealand