Regulatory Affairs Business Product Owner - MedTech

at J&J Family of Companies in Springfield, Illinois, United States

Job Description

Regulatory Affairs Business Product Owner – MedTech – 2406201133W

Description

Johnson & Johnson MedTech is recruiting for a Regulatory Affairs Business Product Owner – MedTech , located in Raritan, NJ or Puerto Rico. Remote work is optional based on the candidate.

At Johnson & Johnson MedTech, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH), Surgical Robotics (OTTAVA), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes.

Overview

The RA Business Product Owner is responsible for driving the product vision, strategy, and roadmap, and for ensuring that the product aligns with the business objectives. The BPO works closely with stakeholders to understand their needs and translates them into actionable tasks to be shared with the IT and Development teams. The BPO is accountable for the product’s success and ensures that it meets the needs of the global MedTech RA community.

This role works closely with the Franchise and Regional Regulatory Affairs groups in the establishment and implementation of lean, harmonized processes across MedTech Global Regulatory Affairs which may be supported by applications and automation to ensure process goals are achieved or exceeded.

The RA Business Product Owner will collaborate with both Regulatory Affairs and IT partners to translate business requirements into application functional specifications in the development of innovative solutions. In this, the role will utilize Process Excellence tools and methodologies to standardize and streamline processes and partner closely with RA Franchise and Regional leaders and SMEs (Subject Matter Experts) to foster continued process improvement.

In this position, the individual is responsible for:

• Collaborating with end users, key SMEs, and business leadership to identify business value of application enhancements, prioritization of development goals, and management of backlog

• Acting as the primary point of contact between business stakeholders and the IT & Development teams, ensuring clear and ongoing communication

• Supporting the development of user stories and providing guidance/clarification in the interpretation of business requirements by the development team

• Participating in quarterly business reviews to plan and prioritize iterations, ensuring a continuous delivery of valuable product increments

• Conducting application demo presentations with summary of improvements and features to leadership, key SMEs, and end users

• Leading MedTech Global Regulatory Affairs in using tools, initiating change, and applying sound process improvement methodology and assisting in the application of appropriate controls to monitor and maintain results and foster continuous improvement

• Supporting the establishment of application performance metrics to measure the effectiveness of current processes/tools

• Managing the development and implementation of application procedures, work instructions and job aides to ensure clear understanding of system processes

• Leading efforts to support and train the global user base in the utilization of established applications including ongoing training and communication activities

• Identifying, benchmarking, and influencing adoption of best practices

Qualifications

Experience and Skills:

Required:

• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives

• Experience with global/regional regulatory software/tools such as MDRIM, TDAL (Technical Documentation Application Layer), Trackwise, etc.

• Strong analytical and problem-solving skills with the ability to make data-driven decisions

• Demonstrated project management skills with strong ability to influence in a highly matrixed environment

• Ability to work collaboratively in a matrixed environment, building partnerships and teamwork across local and global organizations

• Demonstrated written and verbal communications skills, able to quickly build credibility within Franchises and Regions

• Working knowledge of regulatory requirements, processes, and terminology

• Excellent detail orientation and communication skills

+ Bachelor’s Degree with a minimum of (6) years of relevant experience.

Preferred:

+ Experience in leading cross-functional interactions between systems, processes, and business teams

+ Experience with process develop methodologies and tools such as Visio or ProcessPro

+ Familiarity with large datasets, understanding of data processing and analysis workflows

+ Project manager certification

+ Experience with visualization software/tools such as Tableau, PowerBi, etc.

+ Working knowledge of data integration and warehousing

+ Comfortable delivering with minimal oversight

Other:

+ This position can be based in Raritan, NJ or Puerto Rico and requires up to 10% (domestic/international) travel

The anticipated base pay range for this position is [$110,500] to [$138,500].

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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.

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.

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: – 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.

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Primary Location NA-US-New Jersey-Raritan

Other Locations NA-United States, NA-US-Puerto Rico

Organization Medical Device Business Services, Inc (6029)

Job Function Business Systems Analysis

Req ID: 2406201133W