Associate Manager, Regulatory Affairs

2 days ago

Petaling Jaya, Selangor, Malaysia Mason & Co Full time 80,000 - 120,000 per year

About the Company

This company is a rapidly growing multinational organization specializing in the distribution and sale of diagnostic instruments and medical devices. Their products play a critical role in diagnostic testing and are essential to the healthcare ecosystem. With well-established operations in Malaysia, the company continues to strengthen its presence and is now focused on expanding its footprint across the region in a sustainable and strategic manner.

About the Job

In this role, you will lead the Quality Assurance and Regulatory Affairs (QRA) function. You will oversee regulatory and quality activities to ensure compliance with local and regional requirements. You will also work closely with internal teams and regulatory authorities to support the company's growth through strong compliance and quality systems.

Job Responsibilities:

  • Oversee product registrations, business licenses, and certifications to ensure compliance with regulatory requirements.
  • Lead audits and quality initiatives to maintain and improve quality management systems.
  • Monitor regulatory updates and handle compliance matters, including customer and product-related issues.
  • Manage pharmacovigilance activities, including training and reporting, in line with local regulations.
  • Collaborate with internal teams and stakeholders to drive continuous improvement and support business objectives.

Job Requirements:

  • Bachelor's degree in Pharmacy or a related scientific field.
  • Minimum 5 years of experience in regulatory affairs, quality assurance, or compliance within healthcare or life sciences.
  • Good knowledge of product registration processes and regulatory requirements for medical devices and pharmaceuticals.
  • Familiar with quality standards and audits such as ISO 9001, GDP, or GDPMD.
  • Strong leadership, communication, and problem-solving skills.
  • Able to manage multiple priorities effectively in a fast-paced environment.

What's on offer:

  • Exciting career progression opportunities in a rapidly expanding company.
  • Competitive remuneration and benefits.
  • The chance to be part of a growth industry that makes a difference in people's lives.

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