job description
Join Morula IVF, a leading name in reproductive health and fertility solutions, as the Division Head of Medical & Regulatory Affairs. Based in the vibrant and culturally rich island of Bali, this role offers a unique opportunity to lead and shape the medical and regulatory strategies of a pioneering organization in the healthcare sector.
In this high-impact position, you will oversee the compliance, regulatory submissions, and medical governance of our cutting-edge fertility treatments. Your leadership will ensure that Morula IVF maintains the highest standards of patient care, regulatory adherence, and ethical medical practices. This role is ideal for a seasoned professional with a passion for healthcare innovation and a commitment to excellence.
Bali, known for its serene environment and thriving medical tourism industry, provides an inspiring backdrop for this career-defining opportunity. If you are a strategic thinker with a strong background in medical and regulatory affairs, we invite you to apply and become a key driver of our mission to transform lives through advanced fertility solutions.
Responsibility
- Lead and manage the Medical & Regulatory Affairs division, ensuring compliance with local and international healthcare regulations.
- Develop and implement strategies for regulatory submissions, approvals, and ongoing compliance for fertility treatments and medical devices.
- Oversee the preparation and submission of regulatory documentation to authorities such as BPOM (Indonesian FDA) and other relevant bodies.
- Collaborate with cross-functional teams, including medical, legal, and R&D, to ensure alignment with regulatory requirements and company objectives.
- Monitor and analyze changes in healthcare laws and regulations, providing guidance to senior management on potential impacts and necessary adjustments.
- Ensure the highest standards of patient safety, ethical practices, and quality assurance in all medical procedures and regulatory processes.
- Represent Morula IVF in interactions with regulatory agencies, industry associations, and other stakeholders.
- Drive continuous improvement initiatives to enhance regulatory efficiency, reduce risks, and support business growth.
Qualifications
- Bachelor's degree in Medicine, Pharmacy, Life Sciences, or a related field. Advanced degree (e.g., Master's, PhD, MD) is highly preferred.
- Minimum of 10 years of experience in medical and regulatory affairs, with at least 5 years in a leadership role within the healthcare or pharmaceutical industry.
- Proven track record of successful regulatory submissions and approvals in Indonesia or other Southeast Asian markets.
- In-depth knowledge of healthcare regulations, including BPOM guidelines, GCP (Good Clinical Practice), and ISO standards.
- Strong analytical, strategic thinking, and problem-solving skills with the ability to interpret complex regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to engage effectively with regulatory authorities, internal teams, and external partners.
- Experience in fertility treatments, reproductive health, or medical devices is a significant advantage.
- Fluency in English and Bahasa Indonesia; additional languages are a plus.