Regulatory Affairs Manager

2 weeks ago


Inchinnan, Renfrewshire, United Kingdom Terumo Aortic Full time

Terumo Aortic is seeking a highly skilled Regulatory Affairs Team Leader to drive regulatory compliance and strategy across our product portfolio.

Key Responsibilities:

  • Develop and implement regulatory plans and strategies to ensure compliance with international standards and regulations.
  • Lead the preparation and review of regulatory documentation and submissions for product approval, including design dossiers, technical files, and change assessments.
  • Collaborate with cross-functional teams to ensure regulatory compliance in design control, risk management, and post-market surveillance activities.
  • Provide regulatory input and guidance to functional groups, including product packaging, labeling, IFUs, and marketing literature.
  • Facilitate compliance with vigilance systems and ensure regulatory requirements are met.
  • Mentor and develop Regulatory Affairs Associates to ensure a high-performing team.
  • Stay up-to-date with changing regulations and industry developments to ensure Terumo Aortic remains compliant and competitive.

Requirements:

  • Bachelor's degree in a relevant field, such as life sciences, engineering, or regulatory affairs.
  • Proven experience in regulatory affairs, with a strong understanding of international regulations and standards.
  • Excellent communication and leadership skills, with the ability to drive cross-functional teams and collaborate with stakeholders.


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