Senior Regulatory Affairs Associate

Role Overview

• 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.