Regulatory & Quality Assurance Specialist (Medical Devices) - Jakarta, Indonesia - Monroe Consulting Group

Deskripsi

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.