Johnson & Johnson's Medical Devices Division is currently recruiting for a Senior Director, Regulatory Affairs Lifecycle Innovation (RALI), Global Strategy, in support of the Regulatory Affairs Group to be located in the USA.
The Global Surgery and Global Orthopedic Regulatory Affairs Centers of Excellence have recently integrated to support all operating companies under Johnson & Johnson’s Medical Devices Division.
- managing and directing the RALI Global Strategy & Implementation Group (SIG) and the Dossier Excellence Group (DEG) to help create and execute the strategy for planning and obtaining product registrations, and supporting the lifecycle management of Medical Device products from across multiple franchises and business units, in approximately 100 designated countries. This will be achieved through collaboration with internal RA partners and other functional business partners in a matrix environment.
- provide support for Supply Chain and Compliance initiatives that impact marketed products in Wave 2b & 3 countries (e.g., cost improvement and network optimization projects, newly regulated markets, changes in post-market registration requirements). S/he will require the ability to interpret policy changes and assess their impact on W2b and W3 countries in collaboration with the MD RA Policy Team and senior RA leaders.
- collaborate with the RALI leadership team in establishing short and long term strategic goals and directs implementation to achieve objectives. S/he develops and implements the RALI Global SIG and DEG objectives based on organizational priorities and resource availability. S/he plans and directs resources and activities of the groups to deliver business imperatives, maintain product regulatory compliance and sustain market access.
- drive effective business strategies to ensure regulatory programs and projects are standardized to obtain earliest possible approvals. S/he provides measurable input into the development and implementation of Regulatory Affairs processes, standards and plans, in support of the organization’s strategies. S/he drives a culture of Business Process Excellence in partnership with the RALI leadership. This includes establishing consistent, streamlined processes for the group including interfacing with other departments to coordinate the development of regulatory procedures and controls to ensure product compliance in a timely manner, and input on other regulatory processes, systems and metrics.
- manage team development to support business objectives, establishing learning initiatives and training on current and emerging regulatory and related requirements. S/he exercises a high level of independent judgment and execution in anticipating, interpreting, evaluating and resolving complex organizational opportunities whilst appreciating the direct impact on the operational results of the business. These decisions impact portfolio and help shape long-term strategies
- Minimum of a Bachelor’s degree in Life Science, Pharmacy or related discipline is required.
- 12+ years of experience (or an advanced degree and a minimum of 10 years of experience) in a regulated industry is required - Medical Device industry preferred. Experience should include conducting regulatory activities that achieved US &/or foreign regulatory approval of medical devices, consumer, and/or pharmaceutical products.
- Supervisory experience is required. Managing a diverse globally-dispersed team is preferred.
- Demonstrated ability to attract, retain and develop talent is required.
- Must be fluent in English, both written and verbal.
This role will require approximately 25% domestic and international travel and will be based in the USA.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. Primary Location
United States-New Jersey-SomervilleOther Locations
North America-United StatesOrganization
Depuy Orthopaedics. Inc. (6029)Job Function