Director, Regulatory Affairs

Purpose

The Director, Regulatory Affairs is responsible for setting regulatory strategy, and in partnership with cross-functional teams, driving excellence in product innovation, launch and portfolio management. This position is also responsible for providing direction and leadership to the Regulatory Staff in the development and implementation of global regulatory strategies and processes to assure timely commercialization of products in key markets in compliance with current and appropriate worldwide regulatory expectations.

Responsibilities

• Leads and manages activities concerned with the submission and approval products to government regulatory agencies.
• Develops world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
• Administers Regulatory Affairs operations including setting strategic direction and communicates business goals and objectives.
• Oversees the preparation and maintenance of regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of orthopaedic products, including Class III devices.
• Defines the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget.
• Partners with R&D, Quality, Supply Chain, Global Strategic Marketing leaders and other cross-functional 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 product lifecycle management.
• 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 management.
• Establish and ensure deployment of learning initiatives and training of cross functional partners 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 implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
• Inspires, motivates and communicates vision to regulatory associates, peers.
• Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or designate team member).
• Represent Johnson & Johnson's strategic focus area in various internal and external forums and strategy/interactions.

Functional, Leadership, and Technical Competencies

• Connect by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners.
• Shape by anticipating and influencing regulatory changes in key markets to maximize patient access to innovative technologies.
• Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner.
• Deliver by mobilizing and inspiring an accountable team to deliver results for on-time clearances with a global and enterprise-wide mind-set and balance with strategic and short-term goals.
• 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.
• 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.

Qualifications & Experience

• Minimum of a Bachelors' degree within a technical related discipline is required.
• M.S., M.E., PhD or MD is highly preferred.
• Minimum 10 years relevant / regulated industry experience is required.
• Previous experience with medical devices and digital surgical robotics is strongly preferred.
• Senior leadership experience is required, including line management of multiple levels of reporting.
• Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.