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.
The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.
Johnson & Johnson's Neurovascular (CNV) Division is one of the leaders in the medical device industry. Our implants and instruments are used by interventional neuroradiologists, neurosurgeons and neurologists, to treat patients with conditions resulting from hemorrhagic and ischemic stroke. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within Johnson & Johnson.
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
D efining 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
E xercising 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
L eading and developing Regulatory staff to become future leaders
P artnering with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs to platform management
E stablishing and ensure deployment of learning initiatives and training of platform and other franchise personnel on current and emerging regulatory and related requirements
R esponsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
E nsuring that company policies, procedures and practices are in compliance with appropriate regulatory requirements
A ssuring timely regulatory clearances for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and as part of BU RA leadership team develops and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
Inspires, motivates and communicates vision to regulatory associates, peers. The individual serves as a key leader on Platform/Franchise/sub-BU leadership team
Identify and assess external innovation opportunities connected to the platform area of responsibility- both screening & technical due diligence (or designate team member)
Other duties as required.
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