An excellent opportunity has come up with an international Medical Device MNC and they are currently looking for a Regulatory Affairs Assistant to join the team in Singapore.
Responsibilities
- Prepare, compile, and coordinate the submission of regulatory dossiers for medical device registrations in compliance with applicable regulatory requirements.
- Coordinate with regulatory authorities and internal and external stakeholders to facilitate regulatory activities, support product registrations, and address regulatory queries.
- Monitor regulatory submissions and maintain regulatory status records to ensure timely approvals and compliance with regulatory timelines.
- Monitor regulatory developments and communicate relevant updates on local and international medical device regulations to internal stakeholders.
- Maintain and organize regulatory documentation, but not limited to certificates, registration approval/licenses.
- Support regulatory compliance activities, including document reviews, labelling compliance, and other regulatory-related matters.
- Perform other duties and responsibilities as assigned from time to time.
Qualifications
- Bachelor's degree / Diploma in Life Sciences, Pharmacy, or related field
- Minimum 6 months to relevant working experience, preferably in the medical device, pharmaceutical, or life sciences industry.
- Familiarity with medical device regulations and quality management requirements, including ASEAN Medical Device Directive (AMDD), regional regulations in Southeast andSouth Asia, Australia TGA requirements, EU MDR, US FDA regulations, and ISO standards (e.g., ISO 13485).
- Knowledge of or experience in Regulatory Affairs and/or Quality Assurance within the medical device industry is an advantage.
- Proficient in written and spoken English, with effective communication and interpersonal skills.
- Fresh graduates are welcome to apply
If this opportunity excites you, kindly apply with your updated resume in Word format and we will connect shortly for a confidential discussion.
Given the volume of applications, we seek your understanding that only shortlisted candidates will be contacted. Thank you and we truly appreciate your interest.
Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502
