Regulatory Affairs Specialist II

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September 25

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CooperCompanies

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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.

10,000+ employees

Founded 1978

⚕️ Healthcare Insurance

🧬 Biotechnology

☁️ SaaS

💰 Post-IPO Equity on 2021-12

📋 Description

• Perform CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and ROW • Develop product launch strategy, document testing requirements, submission pathways, and anticipated timelines • Interact with FDA, EU Notified Body, and Health Canada; keep updated on country requirements and changes • Participate in change control meetings; review and approve requests; notify Regulatory Bodies of impactful changes • Perform labeling reviews and approvals • Research and consolidate regulatory requirements to develop regional regulatory strategies • Create and maintain registration procedures/protocols and a foreign registration database • Create 510(k) submissions and submit Q-Submission meetings to FDA as needed • Create Technical Files, Design Dossiers and Health Canada notifications; review and maintain technical documentation • Create New License Submissions, Amendments, and Fax Back applications for Health Canada • Respond to regulatory agency questions during review/submissions • Support external audit program; participate in inspections and audits; complete Regulatory CAPAs • Develop and maintain policies and procedures for regulatory submissions and processes • Partner with international regulatory contacts and internal/external stakeholders to plan, develop, and support submissions • Attend and/or lead regulatory meetings

🎯 Requirements

• Preferred Regulatory Experience: Minimum 2-5 years • Preferred 510(k)/Technical File Experience: Minimum 4 years • Preferred FDA/EU submissions and interactions: Minimum 2 years • Bachelor's degree (B. A./B.S.) from four-year college or university OR three to five years related experience and/or training or equivalent combination of education and experience • RAC certification is preferred • Knowledge and understanding of US, EU MDR and international medical device regulations • Ability to work independently with guided supervision • Experience creating 510(k) submissions, Technical Files, Design Dossiers, and Health Canada submissions • Experience interacting with regulatory agencies (FDA, EU Notified Bodies, Health Canada)

🏖️ Benefits

• Outstanding total compensation plan • Great compensation package • Medical coverage • 401(k) • Parental leave • Fertility benefits • Paid time off for vacation, personal, sick and holidays • Multiple other perks and benefits