Regulatory Affairs Specialist

1 month ago


Singapore Avanos Full time

Make a Difference with Your Expertise


We are looking for a talented Regulatory Affairs Specialist to join our team at Avanos. As a key member of our team, you will play a critical role in ensuring the compliance of our medical devices and products with regulatory requirements in the assigned markets.


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 optimal regulatory submission strategies for assigned projects in collaboration with the global team and regional commercial partners.
  • Manage the preparation and submission of regulatory submission packages to relevant health authorities.
  • Identify and communicate issues early in the submission preparation stage that could impact product launch to relevant stakeholders.
  • Work closely and efficiently with the global RAQA team to provide appropriate responses to health authorities' queries during the evaluation process.
  • Coordinate post-marketing approval requirements to ensure compliance at all times.
  • Coordinate post-marketing surveillance activities, such as product recalls and adverse event reporting.
  • Regularly update internal stakeholders on project status and product approvals.
  • Assist in product regulatory due diligence and anticipate regulatory obstacles and emerging issues throughout the product lifecycle.
  • Review and approve labeling and product promotional materials to ensure compliance with regulations and company policy.
  • Keep abreast of current and latest regulations in the region and provide timely assessments on their impact to internal stakeholders.

Requirements:




  • Diploma or Bachelor's degree in life sciences or engineering background is advantageous.
  • Regulatory and quality background in medical devices or life sciences technology-driven companies with at least 2 years of relevant experience.
  • High proficiency in Microsoft Excel, Word, and PowerPoint.
  • Good command of spoken and written English.
  • Team player with ability to work independently with minimum supervision.
  • Knowledge of US FDA and EU medical device regulations is advantageous.
  • Familiarity with IVD, drug-device/device drug, cosmetics, or OTC products is desirable.

About Us:


Avanos is a leading company in the medical device industry, committed to making a difference in the lives of people and communities around the world. We are a dynamic and innovative company that values teamwork, excellence, and customer satisfaction.



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