CooperCompanies
10,000+ employees
Founded 1978
⚕️ Healthcare Insurance
🧬 Biotechnology
☁️ SaaS
💰 Post-IPO Equity on 2021-12
Healthcare Insurance • Biotechnology • SaaS
CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.
Senior Regulatory Affairs Specialist
Job not on LinkedIn
🕒 6 days ago
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CooperCompanies
10,000+ employees
Founded 1978
⚕️ Healthcare Insurance
🧬 Biotechnology
☁️ SaaS
💰 Post-IPO Equity on 2021-12
Healthcare Insurance • Biotechnology • SaaS
CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.
📋 Description
• Lead and support Regulatory projects. • Medical device submissions to US and UK/EU • Drive renewals and product applications with local Authority • Support MDR filling in EU. • Conduct Regulatory impact assessments.
🎯 Requirements
• Master’s degree in pharmaceutical, chemistry or biology or similar • + 4 years of experience from Regulatory affairs -preferable from medical device • Structured and systematic approach • Prior experience with FDA 510(k) and EU MDR 2017/745 • Project management flair and problem-solving skills • Proficient level in MS office • Eye for detail • Fluent English (spoken and written) is mandatory • A can-do attitude, positive mindset and empathic • Team player
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