Regulatory Manager

3 weeks ago

Hong Kong, Central and Western District, Hong Kong SAR China Philips Full time
Job Title: Associate Regulatory Manager

About the Role:

We are seeking an experienced Associate Regulatory Manager to join our team at Philips. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements in Hong Kong and the Greater Bay Area (GBA).

Key Responsibilities:

  • Implement and maintain regular activities on existing HK & GBA approvals, and accelerate compliance to HK& GBA requirements, and meet performance targets.
  • Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into HK, and further approval in GBA if needed.
  • Communicate with relevant competent authorities, agents, distributors, and local sales offices to ensure the most efficient path to application approval.
  • Advise local and international teams on the most expedient route to obtaining product licenses and ensure market access strategy is aligned with local and international marketing/sales requirements.

Requirements:

  • Bachelor's degree or above, major in medical or engineering.
  • 5+ years RA experience on Medical Device, and lead team complete product listing in HK is preferred.
  • A comprehensive understanding of HK medical device regulations.
  • Experience on how to make registration strategy to successfully register different type of medical device in an efficient, effective, and compliant manner.
  • Ability to organize, negotiate, and lead team in strategic discussions with internal and external partners.
  • Eager to continually achieve higher targets both on quality and schedule.
  • Communication and influence skill in daily to solve the problem.

About Philips:

We are a health technology company that believes every human matters. We are committed to providing quality healthcare to everyone, everywhere. If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips.

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