Regulatory Associate

Regulatory Associate
This is an entry-level job, geared towards recent college graduates.

This position starts in JULY of 2026.

This position is an in-office position in Westminster, Colorado.

You will be joining a small, but mighty team and will have the opportunity to experience multiple operational facets of a regulatory affairs career. As an RA team member, you will work closely with the rest of the RA team to ensure distribution of product within regulatory guidelines, and work with international team members to facilitate international submissions. You will have the opportunity to attend surgical labs, engage with project teams, learn about regulatory affairs, hone your writing skills, and immerse yourself in a medical device organization committed to its customers.

Principal Duties and Responsibilities:

• Assist international team members in compiling documentation for international submissions.
• Assist local team members in gathering documentation for US submissions
• Review RA team documentation for readability and mechanics
• Contribute to the development and maintenance of internal work-aides, processes, and procedures
• Support additional regulatory compliance items as required by regulations and as needed by the RA team

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• Strong writing, communication, and interpersonal skills
• Strong attention to detail
• High familiarity with Excel, Word, Sharepoint, and other software tools
• Able to multi-task and balance competing priorities, and willingness to work with changing priorities
• Self-motivated professional who can manage priorities and work independently in a fast-paced environment
• Eager to build relationships between Regulatory Affairs and other teams within the organization
• Ability to communicate effectively

Education/Experience Requirements

• Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
• Combination of education and experience may be considered.

Travel Requirements

Up to 15