Regulatory Affairs Specialist II

Overview

Join to apply for the Regulatory Affairs Specialist II role at Cooper Surgical
.

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 enable patients to experience life’s beautiful moments. We offer over 600 clinically relevant medical devices and an innovative suite of assisted reproductive technology and genomic testing solutions.

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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.
• Work independently at times with guided supervision; may mentor an individual on short-term company initiatives.
• 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, EU Notified Body, and Health Canada; stay updated on 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.
• Research and consolidate regulatory requirements to enable future development of regulatory strategies for all regions.
• Create and maintain registrations procedures/protocols.
• Collaborate with internal and external stakeholders to achieve regulatory goals.
• Create 510(k) submissions for Domestic Market (FDA) and submit Q-Submission Meetings as needed.
• Create Technical Files, Design Dossiers and Health Canada notifications of product changes for CE Marking submissions; review/maintain (MDD) Technical Files and (MDR/IVDR) Technical Documentation after CE Marking.
• Create New License Submissions, Amendments, and Fax Back applications for Health Canada; respond to regulatory agency questions during reviews/submissions.
• Support and assist with external audit programs and participate in inspections and audits by Regulatory Bodies; complete Regulatory Corrective and Preventive Actions from audit findings.
• Develop and maintain policies and procedures regarding regulatory submissions and processes.
• 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; plan, develop and submit product registration applications for new or modified products and/or renewals.
• Coordinate with applicable stakeholders to support submissions and testing requirements; attend and/or lead Regulatory meetings.

• 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 a four-year college or university; or three to five years related experience and/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 and international medical device regulations.

As an employee of Cooper Surgical, you'll receive an outstanding total compensation plan. We offer a comprehensive package including medical coverage, 401(k), parental leave, fertility benefits, paid time off, and other perks. Learn more at

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $75,000.00 - $ annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Legal
• Industries:
  Medical Equipment Manufacturing

We’re not accepting inquiries from search firms for this opening. Referrals can increase your chances of being contacted.

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