job description
Join United Dico Citas as a Technical Responsible Officer (Medical Devices) and play a pivotal role in ensuring the distribution of medical devices complies with CDAKB standards and regulatory requirements. This position is ideal for professionals passionate about healthcare compliance and quality assurance in the medical device industry.
Based in the vibrant region of Badung, Bali, you will collaborate with cross-functional teams to uphold the highest standards of safety, efficacy, and regulatory adherence. Your expertise will directly impact the availability of life-saving medical equipment across Indonesia.
If you are a detail-oriented professional with a strong background in medical device regulations, we invite you to apply and contribute to our mission of delivering excellence in healthcare solutions.
Responsibility
- Ensure compliance of medical devices with CDAKB regulations and other applicable standards.
- Oversee the technical documentation and registration processes for medical devices.
- Coordinate with regulatory authorities to facilitate product approvals and renewals.
- Conduct internal audits to verify adherence to quality management systems (QMS).
- Provide technical training and guidance to internal teams on regulatory requirements.
- Monitor and report on regulatory changes affecting medical device distribution.
- Collaborate with suppliers and distributors to maintain compliance throughout the supply chain.
- Investigate and resolve non-compliance issues promptly.
Qualifications
- Bachelor's degree in Pharmacy, Biomedical Engineering, or related field.
- Minimum 3 years of experience in medical device regulatory affairs or quality assurance.
- In-depth knowledge of CDAKB regulations and international standards (e.g., ISO 13485).
- Strong analytical and problem-solving skills.
- Excellent communication and stakeholder management abilities.
- Proficiency in English and Bahasa Indonesia.
- Certification in regulatory affairs (e.g., RAC) is a plus.
- Ability to work independently and in a team environment.