junior Regulatory Affairs specialistRobert Walters

An exciting Junior Regulatory Affairs Specialist job has become available at a global medical device company.
About the Junior Regulatory Affairs Specialist Role:
In this role, the successful will independently be responsible for product registration on time according to the priority of products defined by the executive team of the company.
Key Responsibilities:
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 following up with the authority on submitted application until approval process. Promptly informing manufacturers on any feedback from the authority to ensure successful product registration
Communicating with customers in respond to their regulatory concerns
Maintaining regulatory database for the company
Preparing 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 the Marketing Manager
Assisting the sales team in discussions with the 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
To be successful with your application, an experience in regulatory affairs for the medical device industry is a huge advantage.
Key Requirements:
Bachelor's degree, post-graduate diploma, professional degree, pharmacy, biology, chemistry, biotechnology, or equivalent
At least one to two years of experience as an RA professional in the medical device industry
Experience in NTC type approval/type acceptance registration is an advantage
Experience in submissions and dealings with National Reference Laboratory is an advantage
The company is a start-up in the Philippines but already has an established presence in APAC
If you are a progressive Junior Regulatory Affairs Specialist with a can-do attitude, this is an excellent opportunity to work with an industry leader that is constantly breaking new ground.
Apply today or contact me to discuss this new opportunity.
Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.
Get in touch
Christine Baloria
+63 2 8841 9319
Robert Walters

Metro Manila
Permanent
Full-time