Regulatory Affairs Specialist II
Company: Katalyst Healthcares & Life Sciences
Posted on: May 28, 2023
- 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
- Maintain current knowledge of FDA, ICH, and international
- 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
- Excellent project management skills with the ability to
- 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
Keywords: Katalyst Healthcares & Life Sciences, Denton , Regulatory Affairs Specialist II, Other , Denton, Texas
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