A rare opportunity has come up with a US medical devices MNC and they are looking for a Regulatory Affairs manager looking for APAC regions, inclusive of ANZ.
You will be responsible for:
- 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.
- Liaise with both internal and external stakeholders to ensure regulatory compliance and provide regulatory advice whenever necessary
- Mentoring and training of internal team of regulatory specialists, APAC affiliates and business units/partners
- Development and implementation of regulatory strategies for various projects to ensure operational excellence and support business requirements
What I am looking out in you:
- Bachelor's degree or equivalent in Medical Science or related scientific discipline
- Minimum 10 years of regulatory experience in medical devices industry is preferred
- Good communications skills in English (both oral and written) to facilitate accurate information flow between departments. Knowledge in Mandarin, Japanese or Korean will be an advantage.
- Ability to travel (up to 40%) as the role covers across APAC and ANZ regions
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).
