Regulatory Affairs Specialist II

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.

As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's 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 women's 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 www.coopersurgical.com .

Work location: Remote position (This role can be located anywhere in the United States)

Scope:

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 receivin...