Regulatory Affairs E-ifu Business Process Manager

Vor 3 Tagen

Baden, Schweiz Johnson & Johnson Vollzeit

The Johnson & Johnson Medical Devices Companies, a part of the Johnson & Johnson Family of Companies is recruiting for a Regulatory Affairs e-IFU Business Process Manager located in Raritan, NJ; New Brunswick, NJ; North America or Switzerland. Remote work options may be considered on a case-by-case basis and 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 e-IFU Business Process Manager is responsible for identifying, planning, and implementing regulatory process-improvement projects, working with stakeholders from within regulatory affairs (franchise and regions) and with business partners to deliver project outcomes. Using process excellence and lean methodologies, this role will: identify and prioritize key regulatory process improvements; lead timely initiation, management, and execution of assigned RA improvement projects; effectively communicate project status, business value, and outcomes through dashboards and metrics. The primary focus of this role will be to create and implement a standardized, global and efficient E2E e-IFU business process for MedTech by collaborating with Quality, Labeling and other key stakeholders. Additionally, this role will establish and lead the governance process for market regulatory information to ensure it is accurate and to identify emerging needs/updates required in order to meet future business needs.

**Key Responsibilities**
- Use Lean Methodology and Process Excellence principals to drive regulatory process improvement projects (e.g., e-IFU) as well as any assigned regulatory projects
- Collaborate with cross-functional business partners to enable effective design and deployment of business processes
- Create, maintain, and monitor KPI metrics to drive efficiency and effectiveness; develop KPI dashboards for communication with business partners
- Establish and lead governance meetings with cross-functional teams, including within Regulatory Operations and GRA, to facilitate strategic planning, execution and maintenance of RA data sources of truth (e.g., e-IFU requirements, market submission requirements, etc)

**Qualifications** Education**:

- Bachelor’s degree or equivalent is required with 8+ years of relevant or regulated industry experience is required

**Experience and Skills**

**Required**:

- Proficiency with Project Management tools and Lean Methodologies is required
- Previous experience working on a globally divers team and/or virtual team is required
- Strong knowledge of global e-labeling regulations and guidance’s for medical devices at a global or regional/local level is required
- Ability to independently makes decisions regarding work processes or operational plans and schedules is required
- Strong experience working within health care regulatory environment such as medical devices, pharmaceuticals, or consumer products is required

**Preferred**:

- Strategic thinking and ability to partner with internal stakeholders at all levels of the organization is preferred
- Ability to achieve results under demanding time constraints with expansive and changing priorities is preferred
- Demonstrated strong leadership, organizational, and planning skills with the ability to work cross-functionally with a diverse work force and customer base - preferred

**Other**:

- This position requires up to 25% domestic/international travel

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.

**Primary Location**
United States-New Jersey-Raritan-1000 US HIghway 202

**Other Locations**
North America-United States, Europe/Middle East/Africa-Switzerland-Aargau-Baden, North America-United States-New Jersey-New Brunswick, Europe/Middle East/Africa-Switzerland-Allschwil, Europe/Middle East/Africa-Switzerland

**Organization**
Medical Device Business Services, Inc (6029)

**Job Function**
Regulatory Affairs

**Requisition ID**
2206071588W

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