Director Regulatory Affairs

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for Director Regulatory Affairs to be based out of Raynham, MA, or West Chester, PA; or Zuchwil, Switzerland.

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.

Job 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) PLTs.
• 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.
• Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies.
• 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).
• Build, sustain, and reward a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
• Leverage expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results.
• Advise and challenge 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/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.
• This position is to be in Raynham, MA, West Chester, PA; or Zuchwil, Switzerland
• May require up to 20% travel.