Job Description
- Define regulatory requirements, develop and execute regulatory strategies in alignment with business goals, leveraging your strong connections within the Ministry of Health to facilitate efficient approvals and clearances. - Develop, implement, and maintain quality management systems (QMS) to ensure compliance with relevant regulations and standards. - Stay abreast of changes in regulatory requirements for medical devices and proactively communicate impact to the organization, ensure that all products are compliant and meets the quality standard. - Ensuring the promotion of awareness of QMS and applicable regulatory requirements throughout the organization. - Other tasks as assigned
Job Requirement
・Min. Bachelor's degree in Pharmacy and have an active Pharmacist license. ・Trained on CDAKB/GDPMD with training certificate from Indonesia MoH and be able to champion the role of Technical PIC with respect to all relevant laws and regulations. ・5-8 years' proven quality assurance and regulatory affairs experience within the medical devices industry. ・Have experience and knowledge on Indonesia medical device product registration. ・Hands on with quality management system including experience in quality audit. ・A robust network of connections within the Ministry of Health or other relevant regulatory authorities. ・Strong leadership skills with people management experience to build and lead high performance teams. ・Exceptional communication and interpersonal skills. ・Meticulous attention to detail and exceptional organizational abilities. ・Capability to work both autonomously and collaboratively within a team setting. ・Flexible and adaptable, willing to take on challenges ・Fluency in English is a must, both written and spoken.