Job Description
About the job
You will join our Life Sciences team to drive a strategic regulatory project focused on medical device licensing and tender requirements in Indonesia. In this role, you will work closely with global stakeholders to deliver fast, high-quality regulatory insights, enabling business expansion through regulatory compliance, market access, and tender readiness.
Your missions
- Provide expert guidance on Indonesian medical device regulations, especially for pediatric use and licensing requirements
- Advise on regulatory requirements for device indications (e.g., pediatric population), labeling updates, clinical evidence, and regulatory pathways
- Support indication expansion strategy and assess feasibility/timeline
- Deliver clear, evidence-based recommendations backed by regulatory references
- Collaborate with global Regulatory Affairs teams (client side) and internal consulting stakeholders across regions
- Contribute to regulatory strategy, risk identification & mitigation, and tender support documentation
Your profile
- Experience in Regulatory Affairs (RA), ideally within the medical devices domain
- Knowledge of Indonesian regulatory framework (BPOM)
- Experience with device registration / licensing, labeling & indication requirements, regulatory submissions and approvals
- Understanding of pediatric device regulations is a strong advantage
- Experience supporting tenders / market access strategy is a plus
- Exposure to medical devices (e.g., diagnostics, imaging, or therapeutic devices) is a plus
- Prior consulting or stakeholder-facing experience is a plus
- Experience working in multi-region/global teams is a plus
- English fluent. Bahasa Indonesia is a plus.
- You demonstrate strong communication skills and can explain complex regulations clearly
- You show a proactive and solution-oriented mindset
- You are comfortable working under tight deadlines
- You demonstrate strong stakeholder management skills across different time zones
What We Offer
- An international community, bringing together 110+ different nationalities
- An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
- A robust training system with our internal Academy and 250+ available modules
- A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
- At Mantu, sustainability is part of everything we do. You'll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you'll be empowered to design and lead projects that create real social or environmental impact, with the company's full support.
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics
Who are we
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
