ID: 672442
Working hours: Mon-Fri 8.30am - 5.30pm
Responsibilities
- Ensure compliance with all applicable regulatory requirements for medical devices, pharmaceuticals, or biotechnology products.
- Prepare and submit regulatory documentation, including applications, reports, and amendments, to regulatory authorities such as the HSA, NEA, FDA, EMA, MHRA, or other relevant bodies.
- Maintain up-to-date knowledge of regulatory requirements and changes in global regulations
- Assist in the preparation and submission of regulatory dossiers for new medical device registrations, renewals, and change notifications.
- Liaise with regulatory agencies to facilitate the approval process and address any queries or deficiencies.
- Liaise with regulatory representatives of various principal medical suppliers for information gathering and product regulatory updates.
- Collaborate with the Quality Assurance team to ensure regulatory compliance of manufacturing and quality control processes.
- Identify and assess regulatory risks associated with product marketing and commercialization.
- Develop risk mitigation strategies to address regulatory challenges.
- Any other ad-hoc assigned.
Requirements
- Candidate must Possess at least a Bachelor’s degree in life sciences, pharmacy, biomedical engineering
- Candidate must have at least 3 years of experience in regulatory affairs within the medical device, pharmaceutical, or biotechnology industry.
- Candidate must be Familiar with relevant regulatory guidelines and standards, including FDA, CE, EMA, ISO, and other international regulations.
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EA Personnel Name: Ray Loh Run Ting
EA Personnel Reg. no.: R1550214
EA License no.: 07C5771
