Regulatory Affairs Specialist for Medical Devices

4 days ago


Lakewood, Washington, United States Terumo BCT Full time

About Terumo BCT

We are a leading global provider of blood and cell technologies, with a strong commitment to innovation and customer satisfaction. Our team is passionate about making a difference in the lives of patients around the world.

Job Summary

This role will be responsible for ensuring compliance with regulatory requirements and standards related to medical devices. The ideal candidate will have a strong background in medical science and experience working with regulatory agencies.

Main Responsibilities

  • Develop and maintain professional relationships with key stakeholders, including regulatory authorities and industry partners
  • Stay up-to-date on changes to regulatory policies and procedures, and ensure that the company's products and processes comply with all relevant requirements
  • Collaborate with cross-functional teams to develop and implement strategies for meeting regulatory needs
  • Analyze data and make recommendations to senior management on regulatory matters

Requirements

  • Advanced degree in a life science or related field
  • Minimum 2 years of experience in a regulatory affairs role, preferably in the medical device industry
  • Strong knowledge of regulatory requirements and standards, including ISO 13485 and FDA regulations
  • Excellent communication and interpersonal skills

What We Offer

We offer a competitive salary range of $147,600 - $184,500, depending on experience and qualifications. Additionally, we provide a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan with a matching contribution.

About the Role

This role is an exciting opportunity to join a dynamic team and contribute to the development of innovative medical devices. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.



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