Regulatory Affairs Senior Specialist IV

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 assigned products governed by US FDA, EU IVDR, Health Canada and ROW regulations
• Responsible for development of product regulatory strategy, submission pathways, and anticipated timelines for defined target markets as it relates to regulatory objectives 
• Partnering with stakeholders and International regulatory contacts to understand testing requirements, submission requirements and submit registration applications/renewals for new and modified products
• 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, including labeling review/approval. Notify Regulatory Bodies of changes that impact regulatory status, etc
• Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions
• Interface with various management levels to ensure that regulatory guidelines and interpretations are enforced in a manner which facilitates business and quality objectives
• Create, maintain and review Technical Files, Design Dossiers and submit notifications of product changes to the designated Regulatory Agency to obtain/maintain CE Marking
• Respond to questions from regulatory agencies during review/submissions
• Develop and maintain policies and procedures regarding to regulatory submissions and processes.
• Support and assist with the external audit program and participate in inspections and audits by Regulatory Bodies
• Draft, review and approve policies and procedures regarding to regulatory submissions and processes to ensure compliance 
• May require the creation 510(k) submissions for Domestic Market (FDA) as well as submissions for Q-Submission Meetings, such as pre-submission and issue meetings, to the FDA as needed
• Complete other projects and duties, as assigned

• BA/BS from four-year college or university; 
• Minimum 6 years of regulatory experience in Biologics or biotechnology with at least4 years EU/Technical file experience and at  least 2 years experience with FDA submissions and interactions. 
• Experience in molecular dx and as a primary point-of-contact for regulators and accrediting bodies, such as FDA, CLIA, AABB and/or AATB preferred. 
• Proficiency in technical writing and the ability to read and understand highly technical material. 
• Advanced skill in the use of Microsoft Excel, Word, and PowerPoint.

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