Regulatory Affairs Specialist with Engineering Expertise

1 week ago


Alameda, California, United States Collabera Full time
Job Overview

We are seeking a highly skilled Regulatory Affairs Associate to join our team at Collabera.

This role will involve working closely with cross-functional teams to manage regulations and ensure compliance with government requirements.

Key Responsibilities
  • Manage regulations and work with cross-functional teams to ensure compliance
  • Analyze and understand regulations before meetings with stakeholders
  • Perform documentation work to identify gaps in processes or product design
  • Filing necessary applications and handling government interactions pertaining to the regulation process
  • Review and approval of engineering study protocols/reports and validation study protocols/reports
  • Review and assessment of emerging regulations
  • May require an advanced degree and 2-4 years of direct experience in the field
Requirements and Qualifications
  • Bachelor's degree in relevant field or equivalent experience
  • Proven track record of managing regulations and ensuring compliance
  • Excellent analytical, communication, and problem-solving skills
  • Ability to work effectively in a fast-paced environment
  • Knowledge of medical devices design controls and Agile PLM system
What We Offer

At Collabera, we offer a competitive salary range of $80,000 - $110,000 per year, depending on experience.

In addition to a competitive salary, we also offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.



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