job description
Join Revo Healthcare Sdn Bhd as a Regulatory and Quality Control Officer and play a pivotal role in ensuring the safety, efficacy, and compliance of cutting-edge medical devices. Based in the vibrant region of Badung, Bali, this position offers a unique opportunity to contribute to global healthcare standards while enjoying a work-life balance in a conducive, employee-centric environment.
In this role, you will oversee regulatory submissions, conduct rigorous quality audits, and collaborate with cross-functional teams to maintain adherence to international standards such as ISO 13485, FDA 21 CFR, and EU MDR. Your expertise will directly impact patient safety and product integrity, making this a highly rewarding career path for professionals passionate about healthcare compliance.
At Revo Healthcare, we prioritize employee wellbeing, offering a supportive culture, professional growth opportunities, and a dynamic workspace in one of Indonesia’s most sought-after locations.
Responsibility
- Develop, implement, and maintain regulatory compliance strategies for medical devices in accordance with local and international standards (e.g., ISO 13485, FDA, CE Marking).
- Prepare and submit regulatory documentation (e.g., 510(k), Technical Files, Design Dossiers) to authorities such as NPRA, FDA, and Notified Bodies.
- Conduct internal and external quality audits to ensure adherence to GMP, QSR, and other applicable regulations.
- Monitor and evaluate post-market surveillance (PMS) data, including adverse event reporting and complaint handling.
- Collaborate with R&D, manufacturing, and supply chain teams to ensure product compliance throughout the lifecycle.
- Stay updated on emerging regulatory trends and provide training to staff on compliance requirements.
- Lead risk management activities (ISO 14971) and CAPA (Corrective and Preventive Actions) processes.
- Represent the company in regulatory inspections and interactions with health authorities.
Qualifications
- Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or related fields. Advanced degrees (MSc/MBA) are a plus.
- Minimum 3 years of experience in regulatory affairs or quality control within the medical device or pharmaceutical industry.
- In-depth knowledge of international regulatory frameworks (FDA, EU MDR, ASEAN MDD, etc.).
- Experience with quality management systems (QMS) and audit procedures (ISO 13485, 21 CFR Part 820).
- Strong analytical, documentation, and reporting skills with attention to detail.
- Proficiency in English (written and verbal); additional languages are advantageous.
- Certifications such as RAC (Regulatory Affairs Certification) or Lead Auditor (ISO 13485) are highly desirable.
- Ability to work independently and collaboratively in a fast-paced, multicultural environment.