Regulatory Affair Manager

PT MEDISINDO BAHANA; Jakarta Utara; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A health and medical sector company in Jakarta Utara is looking for a professional to handle regulatory compliance and the procurement of medical health products. The ideal candidate must have at least a bachelor's degree relevant to the job, with a preference for pharmacists, and possess strong communication skills in English. Candidates should have minimum 2 years experience in healthcare registration. The position requires a fast learner who can work both in teams and independently.

Qualifications

• Having an active STRA is a must.
• 2+ years experience in healthcare registration process preferred.
• Smart, fast learner, loyal, and honest.

Responsibilities

• Investigate medical device requirements with MOH.
• Maintain regulatory documentation and submit necessary papers.
• Handle communication with overseas suppliers.

Skills

Proficient in English

Experience in healthcare business

Excellent communication skills

Ability to work in a team

Education

Bachelor's degree in relevant field

Job description

Investigating whether the Health Product is a medical device requiring registration with MOH or other government institutions, determining its risk classification and its route of submission.

Preparing and submitting documents related to Initial, Renewal, Variations/Change Notification of medical devices, follow-up until approval process.

Maintaining regulatory documentation database and reviewing product licenses with applicable regulations and technical standards.

Compiling documents and completing the entire process until the product is displayed on the LKPP Online E-Catalogue system.

Liaising with external parties on matters relating to Indonesia medical device regulatory requirements.

Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to the Regulatory Manager.

Trading, sourcing, and procurement of medical health products needed by the sales team.

Responsible for import process and incoming items with the import team.

Responsible for communication with suppliers overseas: products, business discussion, forecast, and Purchase order.

Requirements:

Having an active STRA is a must

Bachelor’s degree (S1) relevant to the job (Pharmacist preferred).

Smart, fast learner, hard worker, loyal, honest, and creative.

Having experience in the healthcare business and registration process for a minimum of 2 years is preferred.

Proficient in English, both spoken and written, with the skill to communicate with overseas suppliers.

Able to handle trading (purchase and import process).

Able to work in a team and individually.

Able to join ASAP.

About Us

PT MEDISINDO BAHANA is a company engaged in the health and medical sector with a focus on innovative products that improve the quality of life of the community.