Associate Regulatory Affairs

5 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time
An exciting new opportunity has come up and a global Medical Device MNC is seeking an experienced Associate RA/QA Manager to join their expanding team in Singapore. The successful incumbent will report to the Head of RA/QA .
Quality Assurance
  • Ensure products delivered meet legal and customers' requirements
  • Drive the quality improvement programs and activities and seek for continuous improvement.
  • Deal with process quality issues; and deal with customers' quality issues & enquiries.
  • Monitor GMP & QA activities of the company for regulatory compliance
  • Outline quality assurance policies and procedures
  • Interpret and comply with quality assurance standards
  • Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies
  • Participates in Regulatory and Customer Audits.
  • Oversee the implementation and ensure efficiency of inspection and quality systems
  • Document quality assurance activities, such as internal audits
  • Analyze customer grievances and other non-compliance issues
  • Providing training for employees to ensure compliance with SOPs
  • Analyze audit outcomes and carry out appropriate corrective procedures
  • Set up and maintain pharmaceutical and medical device quality system in accordance with the company's quality policy
  • Maintain a good documentation system for organizing controlled documents and retaining records of manufacture which enable the complete history of a batch to be traced, readily available and easily traceable
  • Ensure established Quality Management System such as Product Complaint & Recall, Internal &External Audits, Vendor Management, Deviation Management, CAPA, Change Control and Quality Risk Management are effectively implemented, monitored and in compliance with cGMP / authority requirements
Regulatory Affairs
  • Lead the formulation of registration strategy for products/projects. Ensures effective implementation of the strategies and adhere to corporate objectives and business goals.
  • Regulatory knowledge: Maintains a high level of regulatory knowledge on global/regional regulatory requirements and provides regulatory guidance for global counterparts.
  • Agency interactions: Acts as core point of contact to relevant authorities/external organizations (CROs, NBs, etc) for products/projects. Liaises, negotiates and lead interactions, including appropriate documentation of the interaction, decisions and outcomes.
  • Dossier submissions: independently leads the preparation, coordination or monitoring or regulatory submissions. Interacts across APAC and global to obtain and/or provide information/data for regulatory submissions.
  • Coordinates change control responses from APAC countries and stock build if required with supply chain department.
You should have at least 7 years' of RA/QA experience and a relevant science degree.
To be considered for this opportunity, please kindly apply with your updated CV.
Ambrose Chan
Registration Number: R
EA License Number: 17C8502

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