Regulatory Affairs and Quality Assurance Specialist

A Regulatory Affairs and Quality Assurance Specialist (Cardiovascular) job has just become available in a leading global medical devices company that recently expanded to Indonesia and is dedicated to improving the healthcare sector, especially related to cardiovascular devices.

About the Regulatory Affairs and Quality Assurance Specialist Role:
As a Regulatory Affairs and Quality Assurance Specialist (Cardiovascular) based in Jakarta, you will report directly to the APAC Regulatory Affairs Senior Manager.

Key Responsibilities:

• Develop and execute regulatory strategies in alignment with business goals, leveraging your strong connections within the Ministry of Health to facilitate efficient approvals and clearances
• Develop, implement, and maintain quality management systems to ensure compliance with relevant regulations and standards
• Stay abreast of changes in regulatory requirements for medical devices and ensure that the companys quality system aligns with these standards, ensure that all products are compliant and meets the quality standard
• Collaborate with cross-functional teams during product development to ensure that quality is built into the design and manufacturing processes
• Conduct risk assessments and participate in design reviews to identify potential quality issues
• Maintain a robust and organised regulatory documentation system, ensuring completeness, accuracy, and adherence to time lines
• Collaborate seamlessly with cross-functional teams, including R&D, quality assurance, and production, to ensure regulatory compliance throughout the product life cycle
• Establish and maintain quality control processes for incoming materials, in-process production, and finished products
• Coordinate testing activities and ensure that testing protocols are developed and followed

To succeed in this Regulatory Affairs and Quality Assurance Specialist (Cardiovascular) role, you must master the technicalities of medical devices, especially related in cardiovascular devices, and understand the latest regulatory updated related to the industry.

Key Requirements:

• Bachelors degree in a relevant field
• Four to eight years proven regulatory affairs experience within the medical devices industry
• A robust network of connections within the Ministry of Health or other relevant regulatory authorities
• Certification in Quality Management (e.g. ASQ Certified Quality Engineer)
• Experience with software validation in a medical device context
• Familiarity with international regulatory requirements for medical devices
• Profound knowledge of applicable regulations, and international regulatory frameworks
• Exceptional communication and interpersonal skills
• Meticulous attention to detail and exceptional organisational abilities
• Capability to work both autonomously and collaboratively within a team setting
• Fluency in English is a must

This company is the global leader in the medical devices industry. The culture is demanding, but if you are confident and have a can-do attitude, the potential for growth of career is provided. The company is also very focused on developing and training their people to the highest standards.

If you are driven, determined and want to take the next step in your career, this Regulatory Affairs and Quality Assurance Specialist role is for you.

Apply today or contact me to discuss this new opportunity.

Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.