Senior Clinical Affairs ManagerOrbusNeich Medical Company Ltd. • SelangorMalaysia, Selangor, Malaysia
Senior Clinical Affairs Manager
OrbusNeich Medical Company Ltd. • SelangorMalaysia, Selangor, Malaysia
14 hari lalu
Penerangan pekerjaanEnsure all clinical activities adhere to applicable global regulations (e.g., FDA 21 CFR Parts 50, 54, 56, 812; ISO 14155; EU MDR), Good Clinical Practice (GCP), and company SOPs. Serve as the primary clinical representative during regulatory agency interactions and audits (FDA, Notified Body, etc.). Work with quality on serious adverse events (SAEs) and device deficiencies, risk management ensuring timely reporting to regulatory bodies and ethics committees. Bachelor’s degree in a Life Science, Engineering, Nursing, or related field. Minimum of 5+ years of direct experience in clinical affairs within the medical device industry. Proven experience in preparing reports for Class II and / or Class III medical device submission Good knowledge of FDA CFR, EU MDR, ISO 14155, and GCP regulations. Demonstrated experience writing reports for regulatory submission documents. Good project management, communication, and leadership skills. Valid GCP certificate
Job Overview
We are seeking an experienced Senior Manager of Clinical Affairs to lead the planning, execution, and management of our regulatory and quality support. This role is critical for generating the reports with clinical evidence required to achieve regulatory approvals (FDA, CE Mark, etc.), support market access, and ensure post-market surveillance compliance. The ideal candidate is a leader with a deep understanding of medical device regulations, with good project management skills to lead the team and monitor timeline.
Strategic Planning & Leadership
- Lead, mentor, and develop a team of clinical affairs professionals (e.g. CRAs, Clinical Information manager).
- Plan and execute the regulatory support reports in alignment with product development and regulatory submission timelines.
- Provide clinical expertise and guidance to cross-functional teams including R&D, Regulatory Affairs, Marketing, and Quality Assurance.
Regulatory Compliance & Quality
Qualifications & Experience
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Senior Manager • SelangorMalaysia, Selangor, Malaysia
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