Senior Executive Regulatory Affairs

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Jawatan Kosong Posisi Senior Executive Regulatory Affairs di

DESKRIPSI Jawatan Kosong

JOB DESCRIPTIONS

  • Ensure products manufactured or distributed comply with the required regulations/standards.
  • Develop, register, facilitate and maintain all regulatory submissions related to establishment and product registration with applicable Regulatory Authority.
  • Liaising with regulatory authorities, designated agents, and notified bodies on all regulatory-related matters.
  • Provide regulatory support to product development and current marketed product.
  • Keep up to date with changes in regulatory, statutory, and QMS requirements.
  • Ensure company compliance with required regulatory, statutory, and QMS requirements.
  • Review and update regulatory and QMS documentations.
  • Review labelling, storage, and packaging requirements in accordance with regulatory requirements to ensure compliance in product labelling.
  • Participates in post-market surveillance activities by conducting routine systematic literature reviews.
  • Handle quality- and regulatory-related matters with Customers and Suppliers (including contract manufacturers).
  • Manage Supplier’s quality and follow up on Supplier Corrective Action Report (SCAR).

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JOB REQUIREMENTS

  • Bachelor’s Degree in Science or equivalent.
  • Minimum 3 years of experience in medical device regulatory position or similar roles and responsibilities is preferred.
  • Experience in ISO 13485, MDA and GDPMD.
  • Products testing, licensing, registration, and certification.
  • Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).

Informasi Tambahan Jawatan Kosong

Tingkat Pekerjaan : Senior Executive
Kualifikasi : Healthcare, Pharmacy
Pengalaman Kerja : 3 years
Jenis Pekerjaan : Full-Time
Spesialisasi Pekerjaan : Healthcare, Pharmacy / 513, 112

Informasi perusahaan Pemberi Kerja,

Today, the principles of innovation and reliability continue to be instilled in our manufacturing process. Our premium healthcare brands enable better care, improved well being and enhanced living for everyone, across the globe. We are dedicated to growing this vision through our passion for innovation, service, and commitment to providing high quality products.

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Informasi Tambahan Perusahaan

Ukuran Perusahaan :
Waktu Proses Lamaran :
Industri :
Tunjangan dan Lain-lain :
Lokasi : Kuala Lumpur