job description
Join UMediC Healthcare as a Regulatory Affairs Executive and play a pivotal role in ensuring our medical devices meet all local and international compliance standards. Based in the vibrant region of Badung, Bali, you will be at the forefront of navigating complex regulatory landscapes, securing approvals, and maintaining our commitment to patient safety and product excellence.
This is a unique opportunity for a detail-oriented professional to contribute to a dynamic healthcare organization while enjoying the work-life balance that Bali’s inspiring environment offers. Your expertise will directly impact our ability to deliver cutting-edge medical solutions to markets worldwide.
If you are passionate about regulatory compliance, thrive in a collaborative setting, and want to advance your career in the medical device industry, we invite you to apply today.
Responsibility
- Develop and implement regulatory strategies to ensure timely approval of medical devices in compliance with local (e.g., Indonesian FDA) and international regulations (e.g., FDA, CE, MHLW).
- Prepare, review, and submit regulatory documentation, including technical files, 510(k) submissions, and CE marking dossiers.
- Monitor and interpret changes in regulatory requirements, advising internal teams on necessary adjustments to maintain compliance.
- Liaise with regulatory authorities, notified bodies, and external consultants to facilitate product registrations and resolve compliance issues.
- Conduct risk assessments and ensure adherence to quality management systems (e.g., ISO 13485) and post-market surveillance requirements.
- Collaborate with R&D, manufacturing, and quality assurance teams to integrate regulatory considerations into product development lifecycle.
- Maintain and update regulatory databases, ensuring accurate record-keeping of submissions, approvals, and certifications.
- Provide training and guidance to cross-functional teams on regulatory policies, procedures, and best practices.
Qualifications
- Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field. Advanced degrees (e.g., Master’s in Regulatory Affairs) are a plus.
- Minimum 3-5 years of experience in regulatory affairs, preferably within the medical device or healthcare industry.
- In-depth knowledge of Indonesian regulatory requirements (e.g., BPPOM) and familiarity with international standards (e.g., FDA 21 CFR, EU MDR).
- Proven track record of successful product registrations, submissions, and compliance audits.
- Strong analytical, problem-solving, and project management skills with the ability to handle multiple priorities in a fast-paced environment.
- Excellent written and verbal communication skills in English; proficiency in Indonesian is advantageous.
- Detail-oriented with a high degree of accuracy in documentation and reporting.
- Certifications such as RAC (Regulatory Affairs Certification) are highly desirable.