Regulatory Affairs Specialist II

About Cooper Surgical

Cooper Surgical 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 Cooper Companies, 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. Learn more at

Work location: Remote position (This role can be located anywhere in the United States)

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. Has the ability to work independently at times, with guided supervision. May be required to mentor an individual on short‑term company initiatives.

• 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 registration 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 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.

Experience:

• 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.

Education:

• Bachelor’s degree (B.
  
  A./B.S.) from four‑year college or university; or three to five years…