Global Regulatory Affairs Specialist II

4 weeks ago


Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time
Job Title: Global Regulatory Affairs Specialist II

Waters Corporation is seeking a highly skilled Global Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance and support for new product development, change management, and post-market activities.

Responsibilities:
  • Develop and maintain regulatory strategies for new and modified products, including international registrations and product labeling.
  • Provide regulatory guidance on changes to existing products, including engineering changes and post-market surveillance activities.
  • Monitor global regulatory intelligence and provide impact evaluations to changing regulations.
  • Prepare and execute regulatory filings, including technical files, Canadian submissions, and letters to file.
  • Support the development and maintenance of regulatory compliance programs, including training and awareness initiatives.
Qualifications:
  • Bachelor's degree in a relevant field, such as analytical chemistry, biochemistry, or biomedical engineering.
  • Minimum 5 years of experience in regulatory affairs, preferably in the in vitro diagnostic medical device environment.
  • Knowledge of 21 CFR 820 and ISO 13485 is required, with experience in European IVD regulations and IVDR preferred.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a global function.
Skills:
  • High fluency in English, verbal and written.
  • Critical thinking, active listening, and technical writing skills.
  • Ability to work effectively in a global function, with strong organization and prioritization skills.
  • Outstanding work ethic and effective communication and influencing skills.


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