Quality & Regulatory Affairs Manager
PT Medela Potentia Tbk. (NOT VERIFIED)
- South Tangerang, IndonesiaTitan Center Lt. 12 | Jl. Boulevard Bintaro Blok B7/B1 No. 5 Bintaro Jaya Sektor 7, South Tangerang, Banten, IndonesiaSouth TangerangBantenIndonesiaIndonesia
- Full timeFULL_TIME
Job closed.
Job Description
- Analyze regulatory rules and their impact on the company
- Provide strategic input to management regarding regulations
- Ensure and monitor compliance with the applicable ISO 27001 standards
- Educate, review, and ensure that pharmacy merchants comply with the applicable regulations
- Manage internal documentation systems (policy, SOP, WI, form)
- Coordinate with internal, external, and government parties to ensure audits are conducted smoothly
Minimum Qualifications
- Min. 5 year of experience in regulatory compliance, risk management, or audit processes, from pharmaceutical background
- Have established relationships with BPOM, Kemenkes, Komdigi, or other government institutions related to digital healthcare regulations
- Strong understanding of healthcare, pharmaceutical, and digital trade regulations
- Able to develop and implement internal compliance policies and documentation
- Proactive, strategic thinker, and able to work across functions
Jobs Summary
- Job Level
- Mid-Senior Level / Manager
- Job Category
- Safety and Security
- Educational Requirement
- Bachelor's degree graduate
- Recruiter response to application
- Often
- Office Address
- Titan Center Lt. 12 | Jl. Boulevard Bintaro Blok B7/B1 No. 5 Bintaro Jaya Sektor 7, South Tangerang, Banten, Indonesia
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About PT Medela Potentia Tbk.
PT Medela Potentia Tbk. is a trusted and leading global healthcare group with over 40 years of experience in the pharmaceutical industry, providing high-quality healthcare services to communities worldwide. Established in 1980, we have built a strong, independent distribution network and professional marketing scale across Indonesia.
Our operations focus on optimizing business analysis, storage, distribution, and managing cold chain products. We are committed to advancing customer needs through the adoption of cutting-edge technology in all aspects of our business operations.
As part of our global group, PT. Anugrah Argon Medica, PT. Djembatan Dua, PT. Deca Metric Medica, Dynamic Argon Co., Ltd, and PT. Karsa Inti Tuju Askara work together to deliver significant added value to our customers and business partners.
In our mission to advance global healthcare services, we are looking for candidates with high enthusiasm to grow with us and help shape a brighter future.