Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

At Siemens Healthineers, our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Varian – A Siemens Healthineers Company’s vision is a world without fear of cancer. To meet this challenge, we equip the world with new tools for fighting cancer.

Our history is one of pioneering developments in the fields of radiotherapy, radiosurgery, X-ray tube technology, digital image detectors, cargo screening, and non-destructive testing. We have a robust product portfolio and long-standing relationships with many of the world’s leading clinicians.

Apply now for the position of Senior Regulatory Officer, where you will be responsible for driving accelerated market access for cancer care solutions, ensuring robust regulatory compliance and local licensing excellence across the region.

Your Role:

• You will lead the compilation, preparation, and timely submission of high-quality registration dossiers for new medical devices, product variations, and license renewals.
• You will manage and monitor local licensing and clearances (Ministry of Health (MOH)-NIE, Distribution License/IDAK, BAPETEN, Menkominfo) and E-Katalog (LKPP) listings to ensure seamless product introductions.
• You will provide product lifecycle regulatory input to accelerate market launch and ensure continuous compliance with zero license gaps.
• You will review and assess product labeling, packaging, and promotional materials to ensure compliance with local regulations and company policies.
• You will proactively monitor local medical device regulation changes, evaluate their business impact, and ensure continuous organizational compliance.
• You will manage post-market surveillance, including Adverse Event (AE), Field Safety Corrective Action (FSCA), and recall regulatory requirements.
• You will develop, implement, and continuously improve SOPs and documentation control systems to ensure compliance and audit readiness
• You will establish strong relationships with local authorities and drive regulatory advocacy to support business objectives.
• You will support regulatory activities across Indonesia and other ASEAN markets, including direct ownership of selected country submissions and regional initiatives.

Your Expertise:

• You hold a bachelor’s degree or equivalent in Pharmacy, Biomedical Engineering, or a related scientific field.
• You have a minimum 5-7 years of relevant experience in regulatory affairs within the medical device industry.
• You have rich experience dealing with Indonesian Ministry of Health (MOH) and solid understanding of the regulations.
• Your experience with BAPETEN and Menkominfo is an advantage.
• You are attentive to details and have a constructive mindset and excellent cross-functional collaboration skills.
• You are proficient in spoken and written English and Bahasa Indonesia.

To find out more about the specific business, have a look at https://www.varian.com/.

Who we are:
We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To all recruitment agencies:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.