CooperSurgical · 11 hours ago
Regulatory Affairs Specialist II
United States
Full-time
Remote
Mid, Senior Level
$75K/yr - $100K/yr
2+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients throughout their lifetimes. The Regulatory Affairs Specialist II will oversee and manage the regulatory process for medical devices, ensuring compliance with various regulatory agencies and facilitating product approvals.
Health CareMedical DeviceWomen's
Hiring Manager
Katie A.
Responsibilities
Responsible for performing CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and rest of the world (ROW)
Responsible for development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets
Responsible for the interactions with the FDA, the EU Notified Body, and Health Canada. Keep updated on all country requirements and changes
Participate in change control meetings. Review and approve requests. Notify Regulatory Bodies of changes that impact clearances, licenses, etc
Perform labeling reviews/approvals as required
Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions
Create and maintain registrations procedures/protocols
Work closely with internal and external customers to achieve success
Additional duties and/or modifications to job description may occur at any time
Create 510(k) submissions for Domestic Market (FDA). Submit Q-Submission Meetings, such as pre-submission and issue meetings, to the FDA as needed
Create Technical Files, Design Dossiers and Health Canada notifications of product changes for submission to the designated Regulatory Agency to obtain/maintain CE Marking
Review and Maintain (MDD) Technical Files and Design Dossier/(MDR/IVDR) Technical Documentation after receiving CE Marking
Create New License Submissions, Amendments, and Fax Back applications for Health Canada
Respond to questions from regulatory agencies during review/submissions
Support and assist with the external audit program and participate in inspections and audits by Regulatory Bodies
Complete Regulatory Corrective and Preventive Actions generated from audit findings
Develop and maintain policies and procedures regarding to regulatory submissions and processes
Create and maintain, a foreign registration database of all current in country registrations and licenses
Partnering with International regulatory contacts to understand requirements for product registrations for new and modified products
Partnering with International regulatory contacts to plan, develop and submit product registration applications for new, modified products and/or registration renewals
Coordinate with applicable stakeholders, to support submissions and testing requirements
Attend and/or lead Regulatory meetings
Qualification
Required
Minimum 2-5 years of regulatory experience
Minimum 4 years of 510(k)/Technical File experience
Minimum 2 years of FDA/EU submissions and interactions
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
Knowledge and understanding of US, EU MDR and international medical device regulations
Preferred
RAC certification
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal, sick and holidays
Multiple other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
MarketScreener
2025-08-29
2025-08-27
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