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Manager, Regulatory Affairs

Company Name: Johnson & Johnson
Location: Irvine, CA

Job Description

Manager, Regulatory Affairs(Job Number: 1624171001) 


The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Manager, Regulatory Affairs aligned to Advanced Sterilization Products (ASP), located in Irvine, CA. 

You, the Manager, Regulatory Affairs will: 

* Develop appropriate regulatory strategies in alignment with input from leadership and key stakeholders.

* Oversee the regulatory team in the coordination and submission of regulatory documentation to FDA and other regulatory agencies around the world as appropriate.

* Ensure rapid and timely approvals/clearances of new products and provides regulatory support and direction for currently marketed products including interfacing with regulatory agencies as required.

* Interact with regulatory agency personnel to facilitate application approvals and resolve regulatory matters.

* Work with team members and business partners to oversee regulatory aspects of new product launches as well as the impact product changes have on the status of existing approvals.

* Ensure all proposed product modifications are evaluated for regulatory impact.

* Conduct promotional item reviews and collaborate with relevant business partners to ensure that promotional objectives are met without exceeding the scope of product approvals/license.

Job Requirements


* A Bachelor's degree is required.

* A minimum of 8 years of experience within a regulated healthcare industry is required.

* A minimum of 2 years of hands-on experience in medical product Regulatory Affairs is required

* Prior 510(k) or PMA experience strongly preferred.

* CE-marking (MDD/MDR) experience strongly preferred.

* Experience in International Regulatory Affairs is preferred

* Excellent written and verbal communication skills are required.

* Familiarity with FDA 21 CFR Parts 800-1299 is required.

* Familiarity with EU Medical Devices Directive/Medical Device Regulation is preferred.

* Demonstrated ability to make sound decisions under pressure with reasonable foresight as to outcomes is required.

* Strong collaboration skills and strong attention to detail is required.

* The ability to effectively develop, manage and mentor associates to strengthen organizational capabilities is required.

* The ability to work collaboratively in a matrixed environment is required. 

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. 

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