Lead Regulatory Affairs Expert

2 weeks ago

Littleton, Colorado, United States Terumo BCT Full time
Position Overview:
At Terumo Blood and Cell Technologies, we are dedicated to improving patient outcomes globally through our innovative medical devices and solutions. Our team of over 7,000 professionals is committed to advancing healthcare for everyone, everywhere.

Role Summary:
We are currently seeking a highly experienced Principal Regulatory Affairs Specialist to spearhead our submissions process for FDA, Health Canada, and EU MDR. In this pivotal role, you will utilize your extensive knowledge to navigate complex regulatory frameworks, ensuring our groundbreaking healthcare products receive the necessary approvals.

Key Responsibilities:
  • Serve as a recognized authority within the organization, possessing a comprehensive understanding of various functions.
  • Oversee the complete lifecycle of multiple intricate products and projects simultaneously.
  • Act as the primary liaison with regulatory agencies, fostering positive relationships throughout the development stages.
  • Develop innovative solutions to complex regulatory challenges that may impact various business functions.
  • Monitor global regulatory changes and communicate their implications to the organization.
  • Represent specific business sectors as the main contact for regulatory authorities.
  • Review product labeling and advertising materials for compliance with international regulations.
  • Author comprehensive submissions and dossiers, ensuring clarity and consistency.
  • Provide technical guidance and mentorship to regulatory associates and cross-functional teams.
  • Exhibit leadership qualities, combining regulatory expertise with business insight.
Qualifications:

Education:
A Bachelor's degree in physical or biological sciences or engineering is preferred. Equivalent education and experience may also be considered.

Experience:
A minimum of 10 years in Regulatory Affairs is required, with clinical or statistical experience being advantageous.

Skills:
  • Expert knowledge of regulatory issues across multiple product lines and geographies.
  • Proven success in managing regulatory submissions, including CE Mark for Class II-III products, IDEs, INDs, 510(k)s, NDAs, and ANDAs.
  • Advanced understanding of medical device regulations such as CFR 820, ISO 13485, and ISO 62304.
  • Ability to comprehend engineering and scientific principles to support product lifecycle management.
  • Strong analytical and creative problem-solving skills.
  • Excellent communication skills, both verbal and written.
Certificates:
Regulatory Affairs Certification (RAC) is preferred.

Work Environment:
This position may be performed remotely or at our Lakewood, Colorado location.

Travel Requirements:
Occasional travel may be necessary (up to 5%).

Physical Requirements:
  • Typical office environment demands include reading, speaking, hearing, and close vision.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.
Compensation:
The target pay range is competitive and will be determined based on education, experience, and market alignment.

At Terumo Blood and Cell Technologies, we offer a comprehensive benefits package designed to support the well-being of our associates and their families. Our commitment to providing a safe and healthy work environment is paramount, and we are proud to be an Equal Opportunity Affirmative Action Employer.

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