Senior Regulatory Affairs Associate
DeepHealth
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $75,000 - $91,000 per year
Job Level
About the role
- Actively liaise and closely collaborate with global regulatory bodies to support product market entry and maintenance.
- Identify current and new regulatory submission and market entry requirements, providing guidance to the product teams for registration of products.
- Actively manage and maintain the product distribution process to ensure only released product, medical and non-medical, is put on the market.
- Identify and implement tools and/or processes to improve the product distribution and communication process.
- Enforce compliance to applicable standards and escalate to appropriate authorities if needed.
Requirements
- Bachelor’s degree in relevant field (or equivalent experience) required.
- 2+ years of experience working in a regulated industry required.
- Experience with the FDA and Software as a Medical Device preferred.
- Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
- Knowledge and experience submitting global regulatory filings, including but not limited to, North America, APAC, and EMEA regions.
- Experience interacting with US and OUS Regulatory Authorities.
- Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.
- Excellent written and oral communication skills.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionmarket entry requirementsFDA Quality System Regulations21 CFR 1121 CFR 820global regulatory filingsMedical Devices RegulationsISO 13485MDSAPISO 14971
Soft Skills
communication skillscollaborationguidancemanagementcompliance enforcement
Certifications
Bachelor's degree