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Role: Medical Devices Regulatory Consultant

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Key Responsibilities:

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- Provide regulatory strategy and guidance for medical device products across global markets.
- Prepare and review regulatory submissions (e.g., 510(k), CE Mark, MDR/IVDR, and other regional filings).
- Ensure compliance with applicable regulatory requirements (FDA, EU MDR, ISO standards).
- Support product registration, regulatory documentation, and lifecycle management activities.
- Collaborate with cross-functional teams including R&D;, Quality, Clinical, and Manufacturing.
- Monitor regulatory changes and assess impact on ongoing projects.

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Requirements:

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- 8+ years of experience in medical device regulatory affairs.
- Bachelor's degree or higher in Biomedical Engineering, Life Sciences, Medical Technology, Pharmacy,



or a related discipline
- Strong command of EU MDR 2017/745 and/or IVDR 2017/746, including technical documentation requirements, clinical evaluation, and conformity assessment routes
- Working knowledge of FDA regulatory pathways: 510(k) substantial equivalence, PMA, De Novo, and associated submission requirements
- Experience working in or with a regulatory consultancy, notified body, or CRO serving the medical device sector
- Familiarity with quality systems (ISO 13485) and regulatory compliance processes.
- Solid stakeholder communication and project management skills.

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📌 Regulatory Affairs Specialist - Medical Devices (Bunghmun)
🏢 Recognized
📍 Bunghmun