Sr. Regulatory Affairs Specialist

The ideal Senior Regulatory Affairs Specialist candidate will come with a strong regulatory affairs background working within the Medical Device industry. This candidate will also possess proficient interpersonal & organizational skills.

Qualifications:

At least 4 years of Regulatory Affairs experience from the Medical Device industry (Class 1-III devices).

Experience with 510(k) submissions, EPA regulations, EU MDR, & Health Canada License submissions are all highly preferred.

Proficient knowledge of 21 CFR 820, ISO 13485, & MDR QMS are a must-have.

This is a full-time, hybrid opportunity that comes with great pay & an enticing benefits package!

If interested, please apply directly to this job posting. Feel free to reach out with any questions to

***MUST BE A U.S. CITIZEN OR GREEN CARD HOLDER. NO VISA CANDIDATES PLEASE