The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Director of Regulatory Affairs - Innovation Portfolio, to be located in Irvine, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, SEDASYS® and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo
, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
Role Summary and Key Responsibilities
The Director of Regulatory affairs will have oversight and responsibility for:
- defines the strategic regulatory direction for pipeline development and global launch excellence for a significant global platform with dedicated R&D budget
- partners 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
- exercise 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
- will lead and develop Regulatory staff to become future leaders
- partners 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
- establish and ensure deployment of learning initiatives and training of platform and other franchise personnel on current and emerging regulatory and related requirements.
- responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
- Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements
- Assures 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.
Required competencies for this role include, but are not limited to:
- Strategic thinking and ability to partner and Influence key stakeholders at senior levels.
- Leverages expert scientific and technical understanding of medical devices and/or biologics to serve as an expert resource and strategic partner for development and planning throughout the product lifecycle in applicable markets (for example, partnering with business partners to proactively address safety issues).
- Builds, sustains, and rewards a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
- Leverages expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results.
- Advises and challenges others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo. Makes and stands behind complex and difficult decisions in ambiguous situations with a large potential impact on the organization.
- 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 strongly preferred.
- Demonstrated track record of formulating global regulatory strategies that align with business deliverables is required.
- 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 and will require some travel.
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Advanced Sterilization Products (ASP)Job Function