Medical Device Compliance Specialist
4 days ago
About the Role
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Andaman Medical. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.
Main Responsibilities
- Determine whether the Health Product is a medical device requiring registration with MOH, and determine its risk classification and route of submission.
- Prepare and submit applications related to Initial, Renewal, Change Notification of medical device submissions, including follow-up until approval.
- Inform manufacturers promptly if there's any feedback from Authority to ensure successful product registration.
- Respond to customer regulatory concerns.
- Maintain the Company's regulatory database.
- Conduct research and prepare Regulatory Intelligence Reports.
- Monitor emerging trends in industry regulations and provide updates to the Marketing Manager.
- Support sales teams in discussions with clients on regulatory matters.
- Develop and maintain Standard Operating Procedures, local working practices, regulatory affairs policies and procedures.
- Liaise with external parties on medical device regulatory requirements.
Qualifications and Requirements
To be successful in this role, you will need:
- At least a Bachelor's Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
- At least 2 years' experience in the medical device industry and especially in regulatory affairs.
- 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, PowerPoint, etc.).
- Able to operate in a multicultural environment.
- A high level of autonomy at work, yet with a profound team spirit.
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