Regulatory Affairs Specialist

13 hours ago


Singapur, Singapore Avanos Full time
Job Title: Regulatory Affairs Specialist

Avanos is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements in the assigned markets throughout the product lifecycle.

Key Responsibilities:
  • Assist in providing regulatory input and technical guidance to the global RA team on product regulatory requirements in the assigned markets.
  • Coordinate and support the development of optimum regulatory submission strategy for assigned projects in collaboration with the global team and regional commercial partners.
  • Manage the preparation and submission of regulatory submission packages to health authorities.
  • Assist in identifying and communicating issues early in the submission preparation stage that could impact product launch.
  • Work closely with the global RAQA team to provide appropriate responses to health authorities' queries during the evaluation process.
  • Close follow-up with health authorities during the evaluation process to ensure timely regulatory approvals.
Requirements:
  • Diploma or Bachelor's degree in life sciences or engineering background.
  • Regulatory and quality background preferably in medical devices or life sciences technology-driven company with at least 2 years of relevant experience.
  • IT-savvy and highly proficient in Microsoft Excel, Word, and PowerPoint.
  • Good command of spoken and written English.
  • Team player.
  • Ability to work independently with minimum supervision.
Preferred Qualifications:
  • Knowledge of US FDA and EU medical device regulations.
  • Familiarity with IVD, drug-device/device drug, cosmetics, or OTC products.
  • Good business acumen and interpersonal skills.
  • Execution excellence.
  • Entrepreneurial and innovative.
  • Results-oriented and driven individual.
  • Adaptable and agile.


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