Deskripsi Pekerjaan
Join PT Mega Pratama Medicalindo as a Manager Medical Device Product Development and lead the complete product lifecycle of innovative medical devices. You will drive strategic initiatives from initial research and regulatory compliance to market penetration and clinical education. This pivotal role requires a dynamic leader who can navigate complex healthcare regulations while ensuring product-market alignment and commercial success. You'll collaborate with cross-functional teams to develop market-responsive solutions that address unmet clinical needs, while maintaining rigorous quality standards throughout the development process. Your expertise will directly impact patient outcomes by accelerating the delivery of life-enhancing medical technologies to Indonesian and international markets.
Tanggung Jawab
- Lead end-to-end medical device product development lifecycle from concept to commercialization
- Monitor and ensure compliance with global regulations (BPOM, FDA, ISO 13485)
- Develop and execute go-to-market strategies for medical device launches
- Conduct clinical education programs for healthcare professionals and stakeholders
- Manage cross-functional teams including R&D, regulatory affairs, and marketing
- Analyze market trends and competitive landscape to identify growth opportunities
- Oversee product documentation and quality assurance processes
Kualifikasi
- Bachelor's degree in Biomedical Engineering, Pharmacy, or related field; Master's preferred
- 5+ years of experience in medical device product development with 2+ years in management
- Deep knowledge of Indonesian medical device regulations and quality systems
- Proven track record in launching successful medical devices in the ASEAN market
- Strong project management skills with experience in cross-functional leadership
- Excellent analytical skills for market research and competitive positioning
- Fluency in Bahasa Indonesia and English for international collaboration