Regulatory Affairs Specialist

1 day ago


Bradford, Bradford, United Kingdom Clinical Selection Full time
Senior Regulatory Affairs Associate

We are seeking an experienced Regulatory Affairs Specialist to join our medical device organization.

Main Responsibilities:
  • Preparation and submission of regulatory documentation for new products, modifications, and renewals.
  • Development and implementation of strategies for timely approvals, aligning with U.S. and international requirements.
  • Maintenance of compliance with medical device regulations, standards, and guidance documents throughout the product lifecycle.

The ideal candidate will possess technical expertise, attention to detail, and excellent collaboration skills.

Requirements:
  • Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field.
  • Approximately 3 years of experience in Regulatory Affairs within the medical device industry.
  • In-depth understanding of EU MDR, ISO 13485, and other international regulations.

The estimated salary for this role is £45,000 - £60,000 per annum, depending on experience.



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