Ethicon, Inc., a member of Johnson & Johnson's Companies, is recruiting a Regulatory Affairs Global Planning and Execution Manager, to be located in Raritan, New Jersey; Guaynabo, Puerto Rico; Norderstedt, Germany; Livingston, UK; Wokingham, UK; other J&J Ethicon sites may be considered!

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Manager of RA, Global Planning & Execution will be a key partner in the acceleration of market access through supporting international registration as well as the identification, analysis and communication of emerging global regulatory requirements and the broad scope implications of changing regulations. The focus will be the implementation of robust and reliable processes, to achieve and sustain regulatory compliance, and meet the growing global regulatory & business needs for registrations. This role will ensure that the data required across Ethicon is identified and processes are successfully implemented for data driven decisions. This will involve successful partnership across multiple functions and franchises within Ethicon and the medical device sector of Johnson & Johnson, as well as working closely with the equivalent role for Cincinnati, Ohio.

Key Responsibilities :

• Leads cross-platform initiatives as process improvements, Regulatory data management digital solutions, international product portfolio management & planning, emerging regulations, forecasting/planning/capacity process development, implementation, and improvement
• Effect processes for implementation excellence, metrics and resources, applies effective planning and reporting tools to enable risk-based and data-driven decisions, coordinates data and analytics (pipeline, resources, metrics)
• Handle large volume of data, build reports and trend analysis. Use digital solutions for the management and reporting of data
• Deliver on business goals in alignment to emerging needs (sector, franchise, and regional partners)
• Support regulatory strategies to drive and accelerate market access aligned with company business objectives
• Align with the regions and franchise on regulatory submissions, requirements, and execution pathway to ensure timely product approval for key product launches or renewals
• Collaborate with third party vendor suppliers by developing expectations, metrics, goals, and processes for sub-contracted activities

  Ethicon, Inc., a member of Johnson & Johnson's Companies, is recruiting a RA Global Planning and Execution Manager, to be based in located in Raritan, New Jersey; Guaynabo, Puerto Rico; Norderstedt, Germany; Livingston, UK; Wokingham, UK; other J&J Ethicon sites may be considered!

  Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

  The Manager of RA, Global Planning & Execution will be a key partner in the acceleration of market access through supporting international registration as well as the identification, analysis and communication of emerging global regulatory requirements and the broad scope implications of changing regulations. The focus will be the implementation of robust and reliable processes, to achieve and sustain regulatory compliance, and meet the growing global regulatory & business needs for registrations. This role will ensure that the data required across Ethicon is identified and processes are successfully implemented for data driven decisions. This will involve successful partnership across multiple functions and franchises within Ethicon and the medical device sector of Johnson & Johnson, as well as working closely with the equivalent role for Cincinnati, Ohio.

  Key Responsibilities :

• Leads cross-platform initiatives as process improvements, Regulatory data management digital solutions, international product portfolio management & planning, emerging regulations, forecasting/planning/capacity process development, implementation, and improvement
• Effect processes for implementation excellence, metrics and resources, applies effective planning and reporting tools to enable risk-based and data-driven decisions, coordinates data and analytics (pipeline, resources, metrics)
• Handle large volume of data, build reports and trend analysis. Use digital solutions for the management and reporting of data
• Deliver on business goals in alignment to emerging needs (sector, franchise, and regional partners)
• Support regulatory strategies to drive and accelerate market access aligned with company business objectives
• Align with the regions and franchise on regulatory submissions, requirements, and execution pathway to ensure timely product approval for key product launches or renewals
• Collaborate with third party vendor suppliers by developing expectations, metrics, goals, and processes for sub-contracted activities

Qualifications

Education:

• Bachelor’s Degree in a scientific, engineering, or legal disciple is required, Master’s Degree preferred

Required:

• 8 to 10 years of work experience in Regulatory Affairs/Government Affairs/Quality/Compliance/Manufacturing in medical or pharmaceutical companies
• Fluent in written and spoken English, additional languages are an asset.
• Incumbent must be available to work administrative schedule within the host company time zone (EST)
• Experience in Regulatory Affairs medical or consumer or pharmaceutical products for international markets (LATAM, APAC, EU etc.) to maintain the legal status of the products. Ability to articulate country requirements to multiple audiences and to translate regulations into clear data requirements to support registrations
• Result oriented with consistent track record of thinking creatively, crafting strategic solutions to problems with impactful business results and an eagerness to learn
• Demonstrated strong leadership, organizational, and planning skills with the ability to work cross-functionally with a diverse work force and customer base. Ability to partner with and influence others
• The ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers and/ or teams across the organization
• Strong analytical skills, such as data modeling, decision analysis and data visualization
• Experience developing and implementing global regulatory strategies and/or global initiatives in alignment with business needs and with impactful results
• Strong project management experience, process improvement, and problem-solving skills
• May require up to 10% domestic/international travel

Preferred:

• Experience with US and EU medical device regulations
• Experience with the preparation, submission, and approval of regulatory documentation for medical devices
• Project Management Certification from an accredited institution
• Experience navigating a complex organizational structure, with multiple partners and virtual environment, where the situation may be dynamic or ambiguous and helps others to do the same. Uses both formal and informal networks to ensure alignment between actions and organizational objectives

Other:

This position is available for JnJ Flex Model work schedule

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 base pay range in the United States for this position is $111,000 to $192,050

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

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.

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.