Regulatory Affairs Leader
6 days ago
About Our Client
We are a leading glove manufacturer in Malaysia, renowned for our commitment to quality and excellence. With expanding global operations, we seek a seasoned Regulatory Affairs expert to drive compliance and regulatory strategies.
- Ensure products adhere to regional regulations, guidelines, and standards.
- Oversee testing processes, coordinating with external labs, and managing necessary documentation.
- Collaborate with superiors to prepare Purchase Requisitions for glove testing, ensuring timely payments and submissions.
- Maintain and update external documents with new revisions, including standards, regulations, and guidance.
- Revise training materials and procedures according to updated standards and regulations for relevant countries.
- Refresh the product portfolio every six months, guaranteeing compliance and accuracy.
- Evaluate quality standards, ensuring submissions meet strict deadlines and regulatory requirements.
- Manage and update FMEA, Risk Management File, Post Market Surveillance, and Clinical Evaluation records.
- Be prepared for transfer to other departments at the company's discretion.
- Ensure RA areas and storage facilities are audit-ready, complying with Good Distribution Practice (GDP) and current Good Manufacturing Practice (cGMP).
- Promote environmentally responsible practices, adhering to Good Environmental Practices (GEP) and relevant legislation.
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