Regulatory Affairs Specialist II

Job Summary

:

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.

Essential Functions & Accountabilities:

• 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.

Qualifications

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./ 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.

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Our Benefits:

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 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.

For . locations that require disclosure of compensation, the starting base pay for this role is between $75,000.00 - $100,000.00 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.