Sr. Regulatory Affairs Specialist
📋 Role Overview & Responsibilities
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 sam.weiser@lumicity.io
- **MUST BE A U.S. CITIZEN OR GREEN CARD HOLDER. NO VISA CANDIDATES PLEASE.***
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This position is located in Akron, OH with potential relocation and sponsorship assistance depending on candidate qualifications.
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