A Regulatory Affairs Specialist (Hybrid) job has just become available at a global leader in the medical devices industry, dedicated to pioneering innovative solutions that enhance healthcare worldwide.

About the Regulatory Affairs Specialist (Hybrid) Role:
As a Regulatory Affairs Specialist (Hybrid) to be based in Jakarta, you will report directly to the Country Manager and Regional Regulatory Affairs.

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
• Ensure that all medical devices manufactured by the company meet and maintain compliance with the regulatory requirements of the Ministry of Health and other relevant authorities
• Prepare, submit, and oversee regulatory submissions
• Maintain a robust and organised regulatory documentation system, ensuring completeness, accuracy, and adherence to timelines
• Collaborate closely with the quality assurance team to implement and maintain quality systems that align with regulatory standards
• Act as the primary point of contact between the company and regulatory agencies, cultivating strong relationships and facilitating open communication
• Stay current with changes in regulatory requirements, guidelines, and industry trends, advising the organisation on potential impacts
• Prepare for and assist with regulatory audits and inspections, ensuring comprehensive compliance and addressing regulatory concerns
• Collaborate seamlessly with cross-functional teams, including R&D, quality assurance, and production, to ensure regulatory compliance throughout the product lifecycle
• Provide expert guidance on regulatory matters, actively contributing to regulatory strategy development and decision-making

To succeed in this Regulatory Affairs Specialist (Hybrid) role, you must have a strong connection within the Ministry of Health and knows how to cultivate relationship with internal and external stakeholders.

Key Requirements:

• Bachelor's degree in pharmacist or diploma in pharmacy
• Four to eight years of proven regulatory affairs experience within the medical devices industry
• A robust network of connections within the Ministry of Health or other relevant regulatory authorities
• Profound knowledge of applicable regulations and international regulatory frameworks
• Exceptional communication and interpersonal skills
• Meticulous attention to detail and exceptional organisational abilities
• Ability to work both autonomously and collaboratively within a team setting

This company is the global leader in minimal invasion surgery. 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 is the role for you. Great career progression opportunities await the right person in this exciting Regulatory Affairs Specialist (Hybrid) role.

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.