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Regulatory Affairs Specialist

3 weeks ago

Bangkok, Bangkok, Thailand Andaman Medical Full time

Job Overview

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

Responsibilities

Regulatory Affairs Specialist

  • 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 applications related to Initial, Renewal, Change Notification of

medical device submissions, including follow up until approval.

  • 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.

  • Liaising with external parties on matters relating to 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.

Qualifications

  • At least a Bachelor's Degree, Post-Graduate Diploma, Professional Degree, Biology,
  • Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent. Graduated as

pharmacist/apothecary.

  • At least 2 years' experience in the medical device industry and especially in regulatory

affairs.

Key Competencies


• Good management skills


• Fluent English with excellent writing and verbal communication skills


• Result oriented, can work with minimal supervision, and willing to assume increasing levels

of responsibilities.


• Computer literate with advanced skills in Microsoft Office (Word, Power Point, etc..)


• At ease in working in a small structure, start-up-type, where tasks and responsibilities are in

constant move.


• Able to operate in a multicultural environment.


• High level of autonomy at work, yet with profound team-spirit