Senior Regulatory Affairs Specialist (Lafayette, CO)

We are seeking a Senior Regulatory Affairs Specialist to join our team.


In this role you will play a key role in the lifecycle management of OEM products. You will be responsible for modifying existing products, preparing and submitting regulatory filings for the U.S. market and managing EU MDR compliance for the European market. You will collaborate closely with our regional and international teams, working with OEM partners to support the submission process and ensure regulatory requirements are met.

Location: Very strong preference to have candidates working hybrid from Lafayette, CO. Could consider remote from the U.S. for the right candidate.

 

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Additional tasks as assigned

 

Required Knowledge and Experience: 

• Bachelor’s degree with 4+ years of experience in regulatory affairs

OR

• An advanced degree with 2+ years of experience in regulatory affairs

 

Nice to Have

• 4+ years of medical device regulatory affairs experience
• Local to CO and willing to work hybrid for this role
• Experience with global regulatory pathways such as 510(k) and EU MDR
• Background or coursework in quality systems, including familiarity with ISO standards (e.g., ISO 13485), and experience with Quality Management Systems (QMS)