Want to be part of a new organization which is aggressively building their new directive in medical space? A rare opportunity has come up with a medical devices manufacturer who is the market leader in their niche field! They are part of a Fortune 500 conglomerate and they are building their RA team across APAC regions. You will be assuming the role of a Regulatory Affairs and Market Quality Lead, reporting into the Senior Market Quality Manager and RA Director.
You will have the autonomy to lead all RAQA activities in Vietnam and assist the company with developing and implementing Quality and Regulatory strategies.
You will be responsible for:
- Implements and maintains company's QMS across Vietnam and ensures the compliance to local and international regulatory standards and regulations (e.g. ISO 13485, FDA 21 CFR part 820, EU MDD/MDR, etc.)
- Lead local internal audits and host external audits. Maintains an audit readiness program to ensure quality compliance.
- Maintains quality oversight of local distribution and warehouse management processes, licences and certifications.
- Submissions and following up of product registrations to various regulatory bodies in a timely manner. Exercise due diligence in reviewing technical documents to fulfill different regulatory bodies' requirements.
- Post-market surveillance activities, supporting on product complaints, adverse events and recalls.
- Reviews marketing labels for accuracy and compliance with international standards. Ensure promotional materials are approved by health authorities
- Liaise with both internal and external stakeholders to ensure both quality and regulatory compliance and provide advice whenever necessary
What will make you the successful individual:
- Bachelor's degree or equivalent in Bio-engineering, Life Sciences or related scientific discipline
- Minimum 6 years of quality/regulatory experience in medical devices industry is highly advantageous, preferably from an established manufacturer
- Certification in Regulatory Affairs, especially medical devices, is preferred.
- Good communications skills in English (both oral and written) to facilitate accurate information flow between departments.
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).