REGULATORY AFFAIRS STAFF

REQUIREMENTS :

• Bachelors degree in Apothecary or related fields

• Minimum 1 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.

Information :

• Company : Revass Utama Medika
• Position : REGULATORY AFFAIRS STAFF
• Location : Jakarta Timur
• Country : ID