Biological Safety and Regulatory Expert

7 days ago


Limerick, Limerick, Ireland Pale Blue Dot Recruitment Full time
Job Summary

Pale Blue Dot Recruitment is seeking a highly skilled Senior Regulatory Affairs Specialist to join their team. In this role, you will be responsible for developing and implementing regulatory strategies to support the successful registration, approval, and maintenance of company and client products.

Main Responsibilities
  • Develop and implement regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.
  • Respond to requests from notified bodies, competent authorities, and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information.
  • Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required.
Requirements and Qualifications
  • Level 8 Honor's Degree Science or Engineering bachelor's degree/master's with a minimum of 3-5 years relevant experience with medical devices.
  • Regulatory experience in Medical Devices, Pharmaceuticals, or similar regulated industry is required.
  • Understanding of applicable guidelines and regulations, for example experience with ISO 10993.
About Pale Blue Dot Recruitment

Pale Blue Dot Recruitment is a leading recruitment agency specializing in medical device placements. We offer a collaborative and dynamic work environment that fosters growth and development.



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