CooperSurgical
Overview
Regulatory Affairs Senior Specialist at CooperSurgical. CooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients and families with a broad range of medical devices and solutions. Learn more at www.coopersurgical.com. Responsibilities
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 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. Research and consolidate 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. 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 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. Partner with international regulatory contacts to understand requirements for product registrations for new and modified products. Coordinate with applicable stakeholders to support submissions and testing requirements. Attend and/or lead Regulatory meetings. Qualifications
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. Knowledge and understanding of US, EU MDR and international medical device regulations. Regulatory Experience: Minimum 4 years (Required). 510(k)/Technical File Experience: Minimum 4 years (Required). FDA/EU submissions and interactions: Minimum 2 years (Required). As an employee of CooperSurgical, you’ll receive a comprehensive compensation package, including medical coverage, 401(k), parental leave, fertility benefits, paid time off, and other benefits. For details, visit www.coopersurgical.com. EEO statement: 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. Compensation note (for U.S. locations that require disclosure): The starting base pay for this role is between $92,000 - $123,000. The actual base pay depends on various factors and may change. This role may be eligible for other compensation and benefits.
#J-18808-Ljbffr
Regulatory Affairs Senior Specialist at CooperSurgical. CooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients and families with a broad range of medical devices and solutions. Learn more at www.coopersurgical.com. Responsibilities
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 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. Research and consolidate 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. 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 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. Partner with international regulatory contacts to understand requirements for product registrations for new and modified products. Coordinate with applicable stakeholders to support submissions and testing requirements. Attend and/or lead Regulatory meetings. Qualifications
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. Knowledge and understanding of US, EU MDR and international medical device regulations. Regulatory Experience: Minimum 4 years (Required). 510(k)/Technical File Experience: Minimum 4 years (Required). FDA/EU submissions and interactions: Minimum 2 years (Required). As an employee of CooperSurgical, you’ll receive a comprehensive compensation package, including medical coverage, 401(k), parental leave, fertility benefits, paid time off, and other benefits. For details, visit www.coopersurgical.com. EEO statement: 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. Compensation note (for U.S. locations that require disclosure): The starting base pay for this role is between $92,000 - $123,000. The actual base pay depends on various factors and may change. This role may be eligible for other compensation and benefits.
#J-18808-Ljbffr