Director Regulatory Affairs

About the role

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

• Define the strategic regulatory direction for pipeline development and global launch excellence.
• Serve as member of TECA+S RA LT, TECA+S PLTs, including Sports/Soft Tissue, Trauma, CMFT, Bio and Spine (as needed).
• Partner with R&D and Global Strategic Marketing leaders as well as other 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.
• Partner 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.
• Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements.
• Assure 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.
• Inspire, motivate and communicate 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.
• Strategic thinking and ability to partner and Influence key stakeholders at senior levels.
• Leverage 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).

Qualifications/Requirements

• A minimum of a bachelor’s degree is required. An advanced degree is preferred.
• Minimum 10 years relevant / regulated industry experience is required.
• Previous experience with medical devices is required.
• Previous experience with biologics/biomaterials, digital, Class 3 implantable devices is preferred.
• Demonstrated track record of formulating global regulatory strategies that align with business deliverables is required.
• Senior leadership experience is preferred, including line management of multiple levels of reporting.
• Experience working with professional and trade associations is a plus.

Preferred Skills

• Business Writing
• Collaboration
• Compliance Risk
• Continuous Improvement
• Developing Others
• Fact-Based Decision Making
• Inclusive Leadership
• Industry Analysis
• Innovation
• Leadership
• Legal Support
• Operations Management
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Strategic Thinking

Pay

$164,000.00 - $282,900.00

Benefits

• Consolidated Retirement Plan (pension)
• Savings Plan (401(k))
• Long-term incentive program
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year