RA Specialist (Medical Device)

Location: BTS Chongnonsi

Our client, a regulatory and market access consultancy mnc, is specialize in the registration, authorized representation, importation, master distribution, quality assurance and compliance of medical device and in-vitro diagnostics (IVD) in Southeast Asia. Their clients are among the worlds leading Medical Device and IVD Manufacturers. 

Job Functions

• Investigating whether the Health Product is a medical device requiring registration with MOH, 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.
• Promptly inform manufacturer is theres any feedback from Authority to ensure successful product registration.
• Communicating with customers in respond to their regulatory concerns.
• Maintain regulatory database for the Company.
• Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
• Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to Marketing Manager.
• Assist sales team in discussion with client on regulatory related matters (when required).
• Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Liaising with external parties on matters relating to Indonesia medical device regulatory requirements.
• Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
• Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.

Requirements

• Good English
• At least a Bachelors Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
• At least 1 year experience in the medical device industry, especially in regulatory or any related industry. (1-2years for junior / 3years+ for senior)