Regulatory Affairs Specialist

1 week ago


Mansfield, Ohio, United States Collabera Full time
Job Description

Collabera is seeking a Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for planning and executing regulatory strategies for molding and capital tooling projects, assessing post-marketing changes, and leading project teams through regulatory requirements.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with global regulations
  • Assess post-marketing changes and ensure compliance with regulatory requirements
  • Lead project teams through regulatory requirements and ensure timely completion of projects
  • Collaborate with cross-functional teams to ensure regulatory compliance
Requirements:
  • Over five years of experience in medical device regulatory affairs with increasing responsibility
  • Global regulatory affairs knowledge and experience
  • Experience working with technical documentation and Global Submission Summary documentation
  • Bachelor's degree with 4 years of regulatory affairs experience
What We Offer:

Collabera offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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