Regulatory Affairs Strategist

1 day ago


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

We are seeking a highly skilled Regulatory Affairs Strategist to join our team at Collabera, a leading Global Digital Solutions Company.

About the Role

The successful candidate will be responsible for defining and implementing regulatory strategies and priorities in conjunction with management, peers, commercial, and affiliate personnel. This is a highly visible position that requires effective verbal and written communication skills, as well as the ability to negotiate, influence, and manage conflict.

As a key member of our team, you will assist in communicating issues to management through project management tracking and issue briefings. You will also work collaboratively with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.

Key Responsibilities
  • Define and implement regulatory strategies and priorities
  • Communicate issues to management through project management tracking and issue briefings
  • Work collaboratively with internal customers to solve problems and communicate regulatory needs
  • Manage and track broad and strategic projects
Requirements
  • Bachelor's degree in engineering or science
  • Minimum 3 years of experience in regulatory affairs
  • Knowledge of US and/or Canadian regulations or EU and other international medical device regulations relating to product and/or device submissions
  • Hands-on experience with 510k submission, PMA/s, or US Annual report preparation
  • Excellent verbal and written communication skills
  • Able to work effectively in a team environment
What We Offer
  • $80,000 - $110,000 per year, depending on location and experience
  • Ongoing training and professional development opportunities
  • A dynamic and supportive work environment
  • The chance to work on high-profile projects and make a meaningful contribution to our team


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