Regulatory Affairs Specialist

About CooperSurgical

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

• 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.

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• 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.

• Certificates, Licenses, Registrations: RAC certification is preferred.

• Other Skills and Abilities: Knowledge and understanding of US, EU MDR and international medical device regulations.

• 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

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

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.