Regulatory Affairs Lead (Medical Devices)

A leading healthcare company is recruiting for a Regulatory Affairs Lead (Medical Devices) job in Indonesia. In this job, you will play a critical role in ensuring compliance with local regulatory requirements, managing product submissions, and driving the successful approval and launch of innovative medical devices.

About The Regulatory Affairs Lead (Medical Devices) Role

Reporting to a Regulatory Manager, you will be responsible for regulatory guidance to product development teams to ensure design, testing, and documentation align with regulatory expectations.

Key Responsibilities

• Develop, standardise, execute, and approve all regulatory documentation. associated with products in the assigned portfolio to meet compliance. requirements of appropriate Indonesian regulatory bodies
• Collaborate with cross-functional teams to gather necessary technical and clinical data for submissions
• Develop and execute comprehensive regulatory strategies for the successful clearance and approval of medical devices

To succeed in this Regulatory Affairs Lead (Medical Devices) role, you must have a strong background in regulatory affairs, a deep understanding of medical device regulations, and excellent communication and leadership skills.

Key Requirements

• Minimum of eight years' experience in regulatory affairs within the medical devices industry, with specific experience in Indonesia's regulatory environment
• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred
• Proficiency in English and Indonesian languages, both written and spoken
• Proven track record of successful product registrations and approvals in Indonesia, including interactions with regulatory authorities

This prominent company offers you a wide range of opportunities. They have the people and ethos to act with speed, innovation, enterprise and creativity.

If you are driven, determined and want to take the next step in your career, this is the role for you. The culture is demanding, but if you are confident and have can-do attitude, the potential rewards are significant. Great opportunities await the right person in this exciting Regulatory Affairs Lead (Medical Devices) job.

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.