DentonRecruiter Since 2001
the smart solution for Denton jobs

Regulatory Affairs Specialist II

Company: Katalyst Healthcares & Life Sciences
Location: Denton
Posted on: May 28, 2023

Job Description:


  • Prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners to achieve departmental and organizational objectives.
  • Prepare, submit and archive 510(k)s, Letters to File, EUMDR Tech Documents, Change Notifications. Respond to FDA and NB to address submission queries.
  • Provide regulatory support to post-launch business maintenance activities under the guidance of Sr. RA personnel.
  • Review labeling and engineering changes for compliance with regulatory filings
  • Maintain current knowledge of FDA, ICH, and international guidelines.
  • Responsible for other duties and projects as assigned.


    • 2-5 years of regulatory affairs experience.
    • Experience with 510(k)s and EU MDR applications, supplements, change notifications, and approvals.
    • Strong organizational and follow-up skills, as well as attention to detail.
    • General understanding of global and U.S. regulatory processes.
    • Excellent project management skills with the ability to multi-task.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Excellent presentation skills, both written and in platform presentation format.

Keywords: Katalyst Healthcares & Life Sciences, Denton , Regulatory Affairs Specialist II, Other , Denton, Texas

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

Denton RSS job feeds