Ra Digital Data&documentation Spec. Ii

**_Caring for the worldone person at a time” _**inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

**DePuy Synthes **Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.

We are looking for a highly committed:
**RA Specialist II, Digital Data and Documentation in Zuchwil**

**(Permanent)**

**Overall Responsibilities**
- Supporting the day-to-day Strategic Data and Documentation operations within Regulatory Affairs environment.
- Focuses on supporting the business aspects of solution planning, delivery and maintenance processes aligned with Software Development Lifecycle (SDLC) standard methodologies.
- Provides thorough input to (regulatory) IT strategies.
- Understands up-to-date information about the company, industry trends, and strategy relevant information for the IT solution updates.
- Responsible for implementation and trainings of procedures
- Creation of User Acceptance Test (UAT) Scripts and execution of UATs Providing content to processes and trainings platform.
- SME to Technical Documentation and Change Agent to projects/initiatives relate to IT system implementation or enhancements.

**Responsibilities**
- Is supporting the engineering business requirements in IT PLM solution deployments related to Technical Documentation, business improvements (e.g. IT Request for Changes (RfC)), initiatives related to IT system enhancements and further, requirements to be established under the current regulations.
- Works in collaboration with the IT team and other global MD&D and Enterprise organizations and initiatives to ensure consistency in approach.
- Coordinates and harmonization procedures and process updates
- Is supporting project management activities such as business requirements collection (stakeholder management) in IT projects.
- Responsible for implementation and trainings of procedures
- Creation of User Acceptance Test (UAT) Scripts and execution of UATs Providing content to processes and trainings platform.
- SME to Technical Documentation and Change Agent to projects/initiatives relate to IT system implementation or enhancements.

**Qualifications**:
**Education Requirements**
- Bachelor's Degree at minimum within a technical related discipline or comparable education pathway is required.

**Further Education**
- Data science or data management or project management course/training/studies

**Experience**
- Foundational knowledge on MDR 245/2017.
- Experience on data requirements and modelling related to regulations.
- Experienced skills in MS Office (Excel, Word, Access) for data analyses and comparisons.
- Strong analytical skills.
- Understands the regulatory and/or product development framework, legislations and requirement in depth.
- Understands business process design, process improvement methodology, training techniques and has ability to make sophisticated processes simple, preferably at DePuy Synthes.
- Education or certificate in project management methodologies e.g. waterfall, agile scrum etc. recommended.
- Experience in software development as business analyst or SME with operational SDLC (software development life cycle) related activities such as test script creation and/or execution and/or procedure updates is preferred.

**Interpersonal skills/ characteristics**
- Good communication skills and the ability to collaborate effectively with IT partners, management, key vendors, and matrix team members.
- Connect by cultivating external relations with partners in key areas and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners.
- Support shaping by developing and implementing strategies to connect Regulatory needs with electronic data and IT environment.
- Consult to developing a diverse team of talented (regulatory) professionals and transparently communicating in a constructive manner.
- Provides day-to-day instructions and suggested training activities to direct reports, if applicable.
- Consults with team member on further project or activities assignments.

**Other Requirements**
- Lead and support for the development of business requirements for software implementation as well as for writing test scripts (User Acceptance Testing (UAT)) and execution of UATs.
- Collaborating closely with the IT team(s): CaX/PLM, SAP (ERP), MDS (master data).
- Data and document requests from all functions.
- Ensures scope is clear and capabilities are aligned to business need.
- Supporting and