Regulatory & Quality Assurance Specialist (Medical Devices)

  • Jakarta
  • Monroe Consulting Group
Executive recruitment consultant Monroe Consulting Group Indonesia is recruiting on behalf of Multinational Medical Device Company. Our client is seeking for Regulatory & Quality Assurance Specialist position. This job will be based in Jakarta, Indonesia.Job Responsibilities:Ensure compliance with regulatory requirements by monitoring and interpreting applicable laws, regulations, and guidelines related to medical devices.Collaborate with cross-functional teams to develop and maintain regulatory strategies for product submissions, ensuring timely approvals from regulatory authorities.Prepare and submit regulatory filingg.Participate in regulatory agency interactions, such as meetings and responses to inquiries, to facilitate product approvals and maintain positive relationships.Conduct internal audits and assessments to ensure adherence to quality assurance (QA) standards and regulatory compliance.Assist in the development, implementation, and maintenance of quality management systems (QMS) to meet industry standards and regulations.Provide guidance on regulatory and quality issues to internal stakeholders, including R&D, manufacturing, and marketing teams.Monitor and communicate changes in regulatory requirements and industry trends, and assess the impact on the company's products and processes.Collaborate with external partners, such as contract manufacturers and suppliers, to ensure their compliance with regulatory and quality standards.Support post-market surveillance activities, including complaint handling, reporting, and corrective and preventive action (CAPA) processes.Contribute to the continuous improvement of regulatory and QA processes and systems within the organization.Requirements:3 to 5 years of relevant experience in regulatory affairs and quality assurance within the medical device industry.Strong understanding of medical device regulations and standards (FDA, ISO 13485, MDR, etc.).Knowledge of quality management systems and experience in their development and maintenance.Familiarity with risk management processes and methodologies.Excellent communication skills, both written and verbal, for effective interaction with internal teams, regulatory agencies, and external partners.Detail-oriented with strong organizational and project management skills.Ability to stay updated on changes in regulations and industry best practices.