Director of Quality and Regulatory Compliance for East Asia

6 days ago


Changning District, China Maquet (Shanghai) Medical Equipment Co., Full time

About the Role

We are seeking a highly skilled Director of Quality and Regulatory Compliance for our East Asia region. This role will be responsible for providing regulatory and quality leadership for our operations in China, Hong Kong, Taiwan, Macau, and Mongolia.

Key Responsibilities

  1. Work closely with our East Asia QRC teams to ensure compliance with regulatory requirements.
  2. Develop and implement quality programs to ensure compliance with global quality management systems.
  3. Manage regulatory submissions and maintain relationships with local authorities.
  4. Lead quality assurance activities, including auditing and CAPA processing.
  5. Collaborate with our product area RA team to plan and execute regulatory submissions.
  6. Establish and maintain quality systems and processes to ensure compliance with local regulations.

Requirements

  1. Bachelor's degree in science or engineering discipline.
  2. Minimum 15 years of experience in quality and regulatory affairs management in a medical device company.
  3. Strong knowledge of global and local quality requirements, with an emphasis on China NMPA.
  4. Excellent communication and collaboration skills.
  5. Ability to lead and manage teams.

About Us

Getinge is a leading global provider of products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. We are committed to improving clinical results and optimizing workflows for hospitals and life science institutions worldwide.



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