Regulatory Affairs Associate

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

We recognize that employees look and feel different in every company, so it’s important to first describe the principles that will drive success in the role prior to talking about the specific responsibilities and tasks. These are: 
1. An obsessive focus on the customer 
2. Being accountable to the customer as if we were their own employee
3. Understanding that strategy is only as good as the execution - and vice versa 
4. Placing a high value on teamwork
5. People are at the heart of the product

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 2450 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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