Regulatory Affairs, Business Product Owner - MedTech

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function: Technology Product & Platform Management

Job Sub Function: Business Systems Analysis

Job Category: Scientific/Technology

All Job Posting Locations: Bogotá Distrito Capital, Colombia, São Paulo, Brazil

Job Description:

We are searching for the best talent for a Regulatory Affairs, Business Product Owner to support our MedTech business. This is a remote role available in all areas within Brazil & Colombia. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location within these countries to apply.

Purpose: The RA Business Product Owner is responsible for supporting and contributing to 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.

You will be responsible for:

• Collaborating with end users, key SMEs, and business leadership to identify business value of application enhancements, prioritization of development goals, and management and prioritization of backlog.
• Acting as the primary point of contact between business stakeholders and the IT & Development teams, ensuring clear and ongoing communication.
• Supporting the delivery of user stories and providing feedback and guidance/clarification in the interpretation of business requirements by the development team.
• Participating in quarterly PI Planning and sprint planning 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/Requirements:

• Minimum of a Bachelor’s Degree is required.
• At least 3+ years of business experience in a relevant Regulatory Affairs or Business Product Owner role.
• Working knowledge of regulatory requirements, processes, and terminology required.
• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives as required.
• Experience in leading cross-functional interactions between systems, processes, and business teams.
• Strong analytical and problem-solving skills with the ability to make data-driven decisions.
• Demonstrated leadership skills with strong ability to influence in a highly matrixed environment as required.
• Ability to work collaboratively in a matrixed environment, building partnerships and teamwork across local and global organizations as required.
• Demonstrated written and verbal communications skills, able to quickly build credibility within Franchises and Regions.
• Experience in Product Management/Ownership.
• Excellent detail orientation and communication skills.

Preferred Skills/Knowledge:

• Experience with global/regional regulatory software/tools such as MDRIM, TDAL (Technical Documentation Application Layer), Trackwise, etc.
• Experience with process develop methodologies and tools such as Visio or ProcessPro.
• Familiarity with large datasets, understanding of data processing and analysis workflows.
• Product Owner (POPM, CSPO, PSPO, etc) certification.
• Experience with visualization software/tools such as Tableau, PowerBi, etc.
• Experience working in an Agile team.
• Working knowledge of data integration and warehousing.
• Comfortable delivering with minimal oversight.