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Regulatory Affairs Project Manager

1 month ago

Santa Clara, California, United States Collabera Full time
Job Overview

Collabera is seeking a highly skilled Regulatory Affairs Project Leader to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business objectives.

Key Responsibilities

  • Develop and implement regulatory strategies to support business growth and compliance
  • Assist in the preparation and submission of regulatory documents, including 510k submissions and CE Technical Documentation
  • Communicate effectively with internal stakeholders, including management, peers, and commercial teams
  • Manage and track regulatory projects, ensuring timely completion and effective communication of results
  • Collaborate with cross-functional teams to solve problems and communicate regulatory needs

Requirements

  • Bachelor's degree in engineering or science, with a minimum of 3 years of experience in regulatory affairs
  • Strong knowledge of US and/or Canadian regulations, or EU and other international medical device regulations
  • Excellent written and verbal communication skills, with the ability to negotiate, influence, and manage conflict
  • Ability to work effectively in a team environment and manage multiple projects simultaneously

What We Offer

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package