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Meticulous science. Mindfully delivered.
Senior Regulatory Affairs Associate
Location
Massachusetts
Posted
93 days ago
Salary
$75K - $91K / year
Seniority
Senior
Job Description
Senior Regulatory Affairs Associate
DeepHealth
• 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.
Job 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.
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