Global Quality and Regulatory Affairs Leader in East Asia

1 week ago


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

We are seeking a seasoned professional to fill the role of Global Quality and Regulatory Affairs Leader in East Asia, based in Shanghai, China. As part of our commitment to excellence, this individual will lead our quality and regulatory affairs efforts in the region.

About the Role

This is an exciting opportunity for a talented and experienced individual to join our team as a Director of Quality and Regulatory Compliance. The successful candidate will be responsible for providing strategic leadership and direction to our quality and regulatory affairs teams in the East Asia region.

Main Responsibilities
  • Develop and implement quality management systems that meet global standards, with a focus on ensuring compliance with local regulations in the East Asia region.
  • Collaborate with cross-functional teams to identify and mitigate quality risks, and develop strategies to prevent future occurrences.
  • Lead the development and implementation of regulatory strategies to support business growth in the East Asia region, while ensuring compliance with all relevant regulations.
  • Maintain strong relationships with key stakeholders, including country managing directors, business leaders, and regulatory authorities.
About You

We are looking for a highly motivated and results-driven individual with a proven track record of success in quality and regulatory affairs leadership roles. The ideal candidate will possess excellent communication and interpersonal skills, with the ability to work effectively in a fast-paced environment.

Requirements
  • Bachelor's degree in science or engineering discipline.
  • Minimum 15 years related experience in quality and regulatory affairs management in medical device companies.
  • Strong knowledge and experience in global and local quality requirements, with an emphasis on China NMPA.
  • Excellent written and verbal communication skills, with the ability to communicate complex technical information to non-technical stakeholders.
What We Offer

In return for your expertise and dedication, we offer a competitive salary package, including a base salary of RMB 1,200,000 per annum, plus benefits and bonuses. Our company provides a dynamic and supportive work environment, with opportunities for career growth and professional development.

About Us

Maquet (Shanghai) Medical Equipment Co., Ltd. is a leading medical technology company dedicated to improving patient outcomes through innovative products and solutions. With a presence in over 100 countries, we are committed to delivering exceptional value to our customers and partners.



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