**Regulatory & Quality Assurance Specialist (Medical Devices)**:- **Sector**: Monroe Medical Devices (CPO & CRO)- **Contact**: Fani Wahyu Zalika- **Client**: Monroe Consulting Group- **Location**: Jakarta- **Salary**: Negotiable- **Expiry Date**: 22 April 2024- **Job Ref**: BBBH438010_1708572388Executive 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.**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.
