Regulatory Affairs Specialist, International Markets

2 days ago

Shanghai, Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full time

About the Role:

Hydrafacial Trading (Shanghai) Co Ltd (China) is seeking a highly skilled Regulatory Affairs Specialist to join their team. As a key contributor, you will play a vital role in bringing the company's products into new markets and spearheading global medical device/cosmetic regulatory submissions.

Key Responsibilities:

  • Lead all regulatory affairs transactions within the region.
  • Assist with the development of regulatory processes to support the region and all other regulatory submissions, approvals, and inspections.
  • Work on a multi-functional team to determine the correct regulatory strategy in each market the company operates in.
  • Oversight of the preparation and filing of regulatory documents with the FDA and international regulatory bodies; setting the standards for and reviewing all submissions to assure adequacy and accuracy.
  • Communication with representatives of foreign regulatory agencies as needed to advance projects.
  • Manage global trade compliance to support customs clearances.
  • Work closely with internal and external clinical affairs experts to review clinical study protocol and management of studies to support regulatory submissions, data integrity and promotional claims.
  • Keep abreast of changes in the global regulatory regulation landscape and communicate those changes to all stakeholders.

Requirements:

  • 8+ years of combined regulatory affairs experience in the medical device industry, both domestically and internationally.
  • Experience in all regulatory processes and regulations in APAC and EMEA market.
  • Cosmetics experience is a plus.
  • Medical device and quality disciplines required.
  • Bachelor's degree; preferably in a scientific or engineering discipline.
  • Experience with requirements for international product registration.
  • Ability to both understand and write technical documentation is required.
  • Good command in English is fundamental.

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