job description
Join PT. Naramedic Mitra Utama Solution as a Staff Registration Affairs and play a pivotal role in ensuring compliance and regulatory approvals for medical devices, traditional medicines, and cosmetics. This position is ideal for detail-oriented professionals with a passion for regulatory affairs and a commitment to maintaining the highest standards of compliance.
Based in the vibrant regions of Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, and Badung, you will work in a dynamic environment that values precision, efficiency, and regulatory expertise. Your role will be crucial in navigating the complex landscape of healthcare regulations, ensuring that our products meet all necessary legal and safety requirements.
If you are a proactive individual with a strong background in regulatory affairs and a desire to contribute to the healthcare industry, we invite you to apply and become a key member of our team.
Responsibility
- Manage the registration process for medical devices, traditional medicines (PKRT), and cosmetics, ensuring all documentation is accurate and submitted on time.
- Coordinate with regulatory authorities to obtain necessary approvals and licenses for products.
- Monitor and ensure compliance with local and international regulations related to healthcare products.
- Prepare and maintain detailed records of all registration activities, including correspondence with regulatory bodies.
- Collaborate with internal teams, including legal, quality assurance, and product development, to gather necessary information for registration submissions.
- Conduct regular reviews of regulatory requirements to ensure ongoing compliance and identify potential issues.
- Provide guidance and training to internal stakeholders on regulatory processes and requirements.
- Assist in the resolution of any regulatory issues or discrepancies that may arise during the registration process.
Qualifications
- Bachelor's degree in Pharmacy, Biology, Chemistry, or a related field.
- Minimum of 2 years of experience in regulatory affairs, preferably in the healthcare or pharmaceutical industry.
- Strong knowledge of Indonesian regulations related to medical devices, PKRT, and cosmetics.
- Excellent organizational and time management skills, with the ability to manage multiple tasks and deadlines.
- Proficient in Microsoft Office Suite and experience with regulatory databases or software.
- Strong attention to detail and accuracy in preparing and reviewing documentation.
- Excellent communication skills, both written and verbal, with the ability to liaise effectively with regulatory authorities and internal teams.
- Ability to work independently and as part of a team in a fast-paced environment.