Regulatory Affairs Associate

Houston, TX
Full-Time
Part-Time
Internship
First Some Stuff on Us:

Growing organization
50-100% growth targets
2018 – 2 teammates
2019 – 15 teammates
Capital efficient
Work in startup type environment

In short, we want to build a big but small company.

PERKS:
Amazing culture: Happy, Helpful, Humble, Hungry.
Get to work in one of the fastest growing industries in TX – Life Sciences
Part of an amazing team
Flexible time off with pay
Opportunity for growth!

We know that diversity makes for the best problem-solving and creative thinking. We are dedicated to adding new perspectives to the team and encourage everyone to apply if your experience is close to what we are looking for.  

Equal
 Opportunity Employer: Proxima is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

job DESCRIPTION

This individual will be responsible for contributing daily to regulatory affairs projects in either medical devices or pharmaceuticals.

This is a contract, full-time position with the possibility of transitioning to permanent full-time position. This position is open to applicants who are able to commute to an office in Houston, TX. This is not primarily a document management role. Some level of strategic analysis and decision making is necessary for success in this position.

The position is at our office at 240 Holcombe Blvd., Houston, TX.

A Day In the life
  • Conduct regulatory research,including literature research, guidance research, research into similar products and past precedent
  • Contribute to the generation of regulatory documents in the format necessary for FDA
  • Contribute to regulatory submissions for FDA or for clients, including device descriptions and summaries of testing
  • Perform regulatory document management and regulatory document logs for clients
  • Contribute to the writing of subject matter content for blog posts and articles


Must Have Knowledge and Skills
  • Bachelor’s Degree in scientific field is required. 
  • Analytical abilities and problem-solving skills
  • Self-starter
  • Resourcefulness
  • Good communication
Nice to Have Knowledge and Skills
  • Experience with medical devices or biomedical engineering
  • Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards
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