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Regulatory Operations Program Manager - 2306110313WDescriptionThe Johnson & Johnson Medical Devices Companies is recruiting for a Regulatory Affairs Change Program Manager to work on large, global regulatory change implementation programs. This position is based at any of the Johnson & Johnson locations in the United States or Puerto Rico! Remote work options may be considered on a case by case basis if approved by the company.The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.The Regulatory Affairs Change Program Manager is responsible for the regulatory management and delivery of franchise-specific outputs for sector-wide regulatory projects into the global market. This role requires the development of comprehensive RA strategies for global deployment and the monitoring and management of the execution of the regulatory actions required to gain approval in the rest of world markets.The Regulatory Affairs Change Program Manager ensures the appropriate regulatory strategies are developed and executed in support of critical company initiatives managed by the Regulatory Operations Special Projects Team. This role is responsible for working with the central planning and execution teams, with the in-country RA team and/or third-party vendors to ensure the needed regulatory actions are performed to maintain products in the marketplace. Team works in support of all Business Units / Franchises across Medical Devices (except Vision).Position duties & responsibilities:
Develop, maintain, and execute comprehensive RA strategies as part of the Global PMO – for regulated markets for major regulatory change projects
Oversee operational teams by establishing and meaning essential processes, keeping products compliant with local country requirements, and ensuring minimal impact on Supply Chain effectiveness and product disruptions
Creates, maintains, and communicates appropriate program documentation to meet business goals and program objectives
Focus on IT systems (MDRIM) coordination and close liaison with resource to ensure timely solutions to registrations
Identify business process owners and align and implement process changes, identify risks, and escalate as necessary
Ensure effective metrics and program operational milestones are met
Ensure effective communication with key stakeholders to ensure they are well informed as well as understanding stakeholder challenges
Partner with RA Special Projects Global PMO, Planning & Execution teams to ensure alignment on priorities across all programs – as well as understanding of interdependencies
Required Knowledge, Skills, and Abilities:
5 years working in the medical device, pharmaceutical or regulated industry
2 years’ experience working in a complex matrix environment
2 years working in Regulatory Affairs or related area
Working knowledge of regulatory requirements, processes, and terminology
Strong record of delivery, problem solving, working across global teams, process development, project planning, scheduling, and leadership skills
Experience in working as an interface between systems, processes, and business
Demonstrated written and verbal communication skills; able to quickly build credibility within Franchises and Regions
Demonstrated project management skills with strong ability to influence in a highly matrixed environment
Ability to work collaboratively, building partnerships and teamwork
Qualifications
Minimum of a Bachelor’s degree within a technical related field is required. Master’s degree or above is a plus
Minimum 5 years relevant/regulated industry experience
Previous experience with Medical Devices is strongly preferred
Experience working with multiple country regulations
Other:
10% Domestic or International Travel
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
The anticipated base pay range for this position is $111,000 to $192,050
The base pay range for this position in the Bay Area of California is $128,000 to $220,915
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below:
https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.Primary Location NA-US-Puerto Rico-GuaynaboOther Locations NA-United StatesOrganization Medical Device Business Services, Inc (6029)Relocation Eligible: NoTravel Yes, 10 % of the TimeJob Function Regulatory AffairsReq ID: 2306110313W
