CooperSurgical
Fertility Solutions
CooperSurgical Fertility is the global leader in IVF and reproductive genetics, providing innovative products and services for every step in the ART journey. Alongside CooperSurgical Medical Devices, a leader in manufacturing trusted and innovative brands to help improve the health of women, babies and families worldwide, we are owned by The Cooper Companies. Building on the high-quality reputation of our legacy companies ORIGIO, SAGE, Humagen, The Pipette Company (TPC), K-Systems, Research Instruments (RI), Wallace®, LifeGlobal® and CooperGenomics, we provide a trusted system of consumables, equipment, technologies and genetic testing for the complete ART process. Operating as a seamless organization, with unmatched product breadth, scientific knowledge and geographical reach, our unified approach opens the door to extensive possibilities for the future. We can help drive and evolve innovation in line with customer needs; offering tailored product solutions, delivering world-class evidence-based training, and organizing expert-led workshops. As trusted brands, our products and services continue to meet stringent standards, and our high-quality manufacturing facilities and genetic testing laboratories have been specifically designed for the development of ART products and services. Working with experts and key opinion leaders in the field, we have dedicated research and development teams. They are continually developing innovative products, revolutionary technology and services using the latest clinical research, to help improve clinical workflows, processes, productivity and outcomes. In doing this, we aim to increase the quality of our partnerships with clinics across the globe and the quality of treatments for women and families.
The Opportunity
Senior Regulatory Affairs Specialist
US-Remote-
Overview
Oversees/Manages the regulation process for products requiring regulatory agency licensing, registration or clearance, including filing necessary applications/submissions. Coordinates the accumulation of technical information and creates submissions for medical devices for approval, license, registration or clearance in any region.
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Responsibilities
- Responsible for performing CMC activities for assigned products for US, EU MDR/IVDR, Health Canada andrest 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 onall country requirements and changes.
- Participate in change control meetings. Review and approve requests. Notify Regulatory Bodies of changesthat impact clearances, licenses, etc.
- Perform labeling reviews/approvals as required.
- Researching and consolidating regulatory requirements to enable future development of regulatorystrategies 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 submissionto the designated Regulatory Agency to obtain/maintain CE Marking.
- Review and Maintain (MDD) Technical Files and Design Dossier/(MDR/IVDR) Technical Documentationafter 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 RegulatoryBodies.
- 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 newand modified products.
- Partnering with International regulatory contacts to plan, develop and submit product registrationapplications for new, modified products and/or registration renewals.
- Coordinate with applicable stakeholders, to support submissions and testing requirements.
- Attend and/or lead Regulatory meetings.
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Qualifications
- Bachelor’s degree (B. A./B.S.) from four-year college or university; or three to five years related experienceand/or training; or equivalent combination of education and experience
- Certificates, Licenses, Registrations: RAC certification is preferred.
- Other Skills and Abilities: Knowledge and understanding of US, EU MDR/IVDR and international medicaldevice regulations.
- Regulatory: 5 years (Required)
- PMA experience (ideally submissions involving software): 2-3 years
- FDA, EU: 4 years (Required)