Regulatory Affairs Senior Specialist
Regulatory Affairs Senior Specialist
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$ 92000 - 123000
1 Vacancy
Job Description
About CooperSurgical
CooperSurgical is a leading fertility and womens 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 CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.
Responsibilities
Essential Duties and Responsibilities include the following:
- 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
- Bachelors 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.
- 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 youll 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 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 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 U.S. locations that require disclosure of compensation the starting base payfor this role is between $92000 - $123000. The actual base payincludes 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.
Required Experience:
Senior IC
Employment Type
Full-Time
