Regulatory Affairs Manager

17 hours ago


Inchinnan, Renfrewshire, United Kingdom Terumo Aortic Full time

Terumo Aortic is seeking a highly skilled Regulatory Affairs professional to lead our team in ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Develop and implement regulatory strategies for new products and changes to existing products.
  • Prepare and review regulatory documentation and submissions for product approval.
  • Participate in Design Control, Risk Management, and Post Market Surveillance activities.
  • Review and prepare regulatory paperwork in accordance with International standards and new regulations.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Provide regulatory input to functional groups as required.
  • Mentor and develop Regulatory Affairs Associates.

Requirements:

  • BSc Hons Degree or equivalent in a relevant field.
  • Proven experience in Regulatory Affairs, preferably in a medical device industry.

About Terumo Aortic:

We are a leading manufacturer of medical devices and equipment, committed to delivering high-quality products and services that improve patient outcomes.



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