Regulatory Affairs Specialist II

CooperCompanies • Trumbull, CT

107d • $75,000 - $100,000

About The Position

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. This role oversees/manages the regulation process for products requiring regulatory agency licensing, registration, or clearance, including filing necessary applications/submissions. It requires coordination of technical information and creation of submissions for medical devices for approval, license, registration, or clearance in any region. The position allows for independent work with guided supervision and may involve mentoring individuals on short-term company initiatives.

Requirements

• Minimum 2-5 years of preferred regulatory experience.
• Minimum 4 years of preferred 510(k)/Technical File experience.
• Minimum 2 years of preferred FDA/EU submissions and interactions.
• Bachelor's degree (B. A./B.S.) from a 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.

Responsibilities

• Perform CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and rest of the world (ROW).
• Develop product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets.
• Interact with the FDA, the EU Notified Body, and Health Canada, keeping updated on all country requirements and changes.
• Participate in change control meetings, review and approve requests, and notify Regulatory Bodies of changes that impact clearances, licenses, etc.
• Perform labeling reviews/approvals as required.
• Research and consolidate 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.
• Create 510(k) submissions for Domestic Market (FDA) and submit Q-Submission Meetings to the FDA as needed.
• Create Technical Files, Design Dossiers and Health Canada notifications of product changes for submission 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 regulatory submissions and processes.
• Create and maintain a foreign registration database of all current in country registrations and licenses.
• Partner with International regulatory contacts to understand requirements for product registrations for new and modified products.
• Coordinate with applicable stakeholders to support submissions and testing requirements.
• Attend and/or lead Regulatory meetings.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree