Regulatory affairs specialist

24 hours ago


Singapore 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 maximize 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
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 if there’s any feedback from Authority to ensure successful product registration.
Communicating with customers in response 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 discussions with clients 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 awareness of obligations to comply with regulatory requirements and any other applicable statutory requirements and any decisions 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 environment, where tasks and responsibilities are in constant movement.
Able to operate in a multicultural environment.
High level of autonomy at work, yet with a profound team spirit.
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