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Senior Director, Regulatory Affairs

Company Name: Johnson & Johnson
Location: Irvine, CA
Job Type: Full-time
Contact Name:  Human Resources
Phone:  n/a
Fax: n/a
Email: n/a
Salary: DOE

Job Description

Senior Director, Regulatory Affairs(Job Number: 8725170824) 


Johnson & Johnson's Neurovascular Division (CNV), a member of the Medical Device group within Cardiovascular & Specialty Solutions (CSS) is recruiting for a Senior Director, Regulatory Affairs located in Irvine, CA. 

You, the Senior Director, Regulatory Affairs will have oversight and responsibility for: 

* Establishing relationships with regulators in relation to regulatory activities associated with the Neurovascular business; be the key contact person for all regulatory activities with agencies

* Defining the strategic regulatory direction for pipeline development and global launch excellence for a significant global platform with dedicated R&D budget

* Partnering with R&D and Global Strategic Marketing platform leaders as well as other functional platform leaders to develop and implement strategy for pipeline development and global launch excellence

* Exercising highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages, oversees and balances resource allocation across critical projects; and is responsible for regulatory aspects of lifecycle management of platform

* Leading and developing Regulatory staff to become future leaders

Job Requirements 

* Minimum of a B.A./B.S. within a technical related discipline is required. M.S., M.E., PhD or MD is a plus.

* Minimum 15 years relevant / regulated industry experience is required.

* Previous experience with medical devices is required.

* Demonstrated track record of formulating global regulatory strategies that align with business deliverables is required.

* Strategic thinking and ability to partner and Influence key stakeholders at senior levels.

* Senior leadership experience is required, including line management of multiple levels of reporting.

* Experience working with professional and trade associations is a plus. 

This position is located in Irvine, CA and will require up to 30% domestic/ international travel. 

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. 

Primary Location:  North America-United States-California-Irvine 

Organization:  Depuy Orthopaedics. Inc. (6029) 

Job Function:  Regulatory Affairs


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