A renowned medical devices manufacturer in the west is inviting independent and meticulous Senior RA Specialist to take on a 1-year contract role. Reporting to the RA manager, you will be responsible to compile dossiers in preparation of submissions for new products, variations or renewals. You will be interacting frequently with internal and external stakeholders to develop strategies or to update on statuses.
Responsibilities
- Provide guidance to the RA team, serving as the local representative to interact with regulatory agency on regulation requirements and products' submissions/approval.
- Liaise with both internal and external stakeholders to develop regulatory strategies / framework relating to products' intend use, device labelling and indications.
- Monitor and update registration activities and statuses to all relevant stakeholders. Ensure the required actions and responses are in place timely. Identify and report any delay to the registration timeline and involve the relevant stakeholders for discussion on action plan.
- Implementing RA procedures in order to stay compliant with the changing regulatory environment efficiently.
- Ensure proper maintenance & management for existing product licenses and applications, understanding local requirements
Requirements
- A diploma or degree in scientific discipline or equivalent discipline
- Minimum 3 years' working experience in healthcare industry, preferably in medical devices company. Strong knowledge in HSA submissions.
- Good communications skills in English (both oral and written) to facilitate accurate information flow between departments
- Working knowledge of ISO 13485, FDA 21 CFR part 820 will be advantageous.
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).
