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Regulatory Affairs Specialist

4 months ago

Manila, National Capital Region, Philippines ANDAMAN MEDICAL PHILIPPINES CORPORATION Full time

We Are Looking for Applicants Residing in Metro Manila.

Andaman Medical is a young and fast-growing Medical Device Regulatory Affairs & Market Access consultancy. We specialize in the registration, authorized representation, importation, master distribution, quality assurance and compliance of medical device and in-vitro diagnostics (IVD) in Southeast Asia. Our clients are among the world's leading Medical Device and IVD Manufacturers. Our dedicated experts are located in various SEA countries including Malaysia, Singapore, Thailand, Philippines, Vietnam, Cambodia and Indonesia.

Position Overview

This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Consultant is expected to drive best practices in office and administrative management within the organization to maximize efficiency and growth. The main responsibility is to proactively support the organization in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.

Essential Job Functions

Regulatory Affairs

Investigating whether the Health Product is a medical device requiring registration with FDA, determining its risk classification and its route of submission.Preparing and submitting documents related to Initial, Renewal, Variations (Change of Ownership and Change Notification) of medical devices, follow-up until approval process.Constantly follow-up with the Authority on submitted application until approval process. Promptly inform manufacturer is there's 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.Ensuring the GDPMD regulatory compliance system is established, implemented and maintained and reports to top management on the performance of the GDPMD regulatory compliance system, including identifying and correcting deviations from the established GDPMD regulatory compliance system.Liaising with external parties on matters relating to Philippine 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. QualificationsAt least a bachelor's degree, Post-Graduate Diploma, Professional Degree, Pharmacy, Biology, Chemistry, Biotechnology, or equivalent.At least 2 years' experience as an RA professional in the medical device industry.Experience in the registration of various kinds of medical devices and In-vitro diagnosticsExperience in NTC type approval/type acceptance registration is an advantage.Experience in submissions and dealings with National Reference Laboratory is an advantage.