Senior Regulatory Affairs Specialist

5 days ago


Lakewood, United States Terumo BCT Full time
Job Title: Senior Regulatory Affairs Specialist

At Terumo Blood and Cell Technologies, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a pivotal role in ensuring regulatory compliance and driving the success of our innovative medical products.

Key Responsibilities:
  • Develop strategic regulatory plans and expertly navigate submissions to ensure timely approval for market release.
  • Collaborate cross-functionally to address challenges and seize opportunities, leveraging your in-depth knowledge of global medical device and pharmaceutical regulations.
  • Review and analyze product labeling to ensure compliance with applicable US and international regulations.
  • Negotiate and interact with regulatory agencies and certification authorities to ensure submission approval.
  • Identify the need for new or modified regulatory procedures, SOPs, and participate in development and implementation.
Requirements:
  • Bachelor's degree in physical/biological sciences or engineering, or equivalent experience.
  • Seven (7) years' experience in Regulatory Affairs, or a mix of Regulatory and Quality experience in a regulated environment.
  • Excellent written and verbal communication skills, with the ability to prioritize and handle several projects concurrently.
  • Leadership and mentoring skills, with the ability to provide guidance and support to less experienced regulatory personnel.
  • Regulatory Affairs Certification (RAC) preferred.
What We Offer:
  • A competitive total reward package, including salary, benefits, and recognition programs.
  • A collaborative and dynamic work environment, with opportunities for growth and development.
  • The chance to work on innovative medical products that make a real difference in people's lives.


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