REQUIREMENTS :
- Bachelor’s degree in Apothecary or related fileds
- Minimum 2 years of experience as a Regulatory Officer for medical devices and Cosmetic fields
- Ability to work in a team, with excellent communication and negotiation skills.
- Excellent analytical, problem-solving, decision-making, organizational, and time management skills
- Honest, Driven for results, responsible.
- Must have English communication skills (oral & written)
JOB DESC :
- Experienced in medical device and cosmetic registration is a must
- Knowledgeable in e-catalog and KFA processes
- Experienced in IDAK, CDAKB, and other certifications
- Ensuring that the Company complies with applicable laws and Government Regulations as well as the provisions of Good Distribution Practice for Medical Devices as stipulated by the Minister of Health.
- Performing new registrations, amendment, and renewal for product distribution permits.
- Monitoring the validity period of product distribution permits (AKL) and documents related to product specifications and distribution permits, and renewing the distribution permits and related documents before they expire.
- Acting as a liaison between the Company and principles regarding documents related to product specification certificates, import permits, registrations, etc.
- Preparing completeness of documents required in the bidding process for government hospital through LPSE.