Regulatory Affairs Consultant (Medical Devices)

TL;DR

Regulatory Affairs Consultant (Medical Devices): Driving a strategic regulatory project focused on medical device licensing and tender requirements in Indonesia with an accent on BPOM compliance and market access. Focus on delivering regulatory insights, managing indication expansions, and supporting tender documentation for global stakeholders.

Company

Independent technology consulting firm providing guidance and solutions to businesses globally across Information Systems, Telecom, Life Sciences, and Engineering.

What you will do

• Provide expert guidance on Indonesian medical device regulations and BPOM licensing requirements.
• Advise on device indications, labeling updates, clinical evidence, and regulatory pathways.
• Support indication expansion strategy and assess feasibility and timelines.
• Collaborate with global Regulatory Affairs teams and internal consulting stakeholders across regions.
• Deliver evidence-based recommendations backed by regulatory references.
• Contribute to regulatory strategy, risk mitigation, and tender support documentation.

Requirements

• Experience in Regulatory Affairs, ideally within the medical devices domain.
• Deep knowledge of the Indonesian regulatory framework (BPOM).
• Experience with device registration, licensing, labeling, and regulatory submissions.
• English: Fluent (C1) proficiency required.
• Ability to manage stakeholders across different time zones.
• Proven experience working in multi-region or global teams.

Nice to have

• Understanding of pediatric device regulations.
• Experience supporting tenders or market access strategies.
• Proficiency in Bahasa Indonesia.
• Prior consulting or stakeholder-facing experience.
• Exposure to diagnostics, imaging, or therapeutic devices.

Culture & Benefits

• International community with over 110 different nationalities.
• Strong internal growth culture where many leaders started at entry-level roles.
• Robust training system with an internal Academy and 250+ modules.
• Vibrant workplace with frequent internal events and team buildings.
• Opportunity to lead social or environmental projects via the WeCare Together program.

Hiring process

• Brief virtual or phone call to discuss motivations and fit.
• Average of 3 interviews with line managers and team members to assess experience and skills.
• Optional case study, role play, or technical assessment depending on the role.