Johnson & Johnson Careers
Manager R&D, EU Medical Device Regulations
Requisition ID: 6157181031
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Manager, EU MDR, located in preferably Cincinnati, OH, or any US Medical Device Location.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, power tools and biomaterials.
This role works across all J&J medical device businesses (Ethicon, DePuy Synthes, CSS) to lead the transition to new compliance regulations for the European Union (EU). Multiple workstreams make up the EU MDR Program, one of which is the R&D workstream. Multiple sub-streams are within the R&D workstream and includes R&D, Restricted Substances, Design Quality, Biocompatibility and Risk Management. The R&D Sub-stream Lead position resides within the R&D Workstream.
You will be the single point of contact (SPoC) for activities in R&D, Design Quality, and Risk Management. You will be responsible for ensuring that the corresponding sub-stream achieves readiness for the distribution of EU MDR compliant product as well as all other defined deliverables within the established program timelines. You will be successful by partnering with EU MDR Program leaders, platform leaders, and others to ensure process/procedures, organizational changes and system updates have been modified, when necessary, to address the new EU MDR requirements. The R&D Sub-stream Lead will also be responsible for identifying and mitigating risks and reporting on sub-stream progress. This role is a 24-month duration based assignment.
- Responsible for developing the strategy necessary to ensure the successful EU MDR transition for the sub-stream within the designated timeline.
- Leads sub-stream team efforts, as it pertains to the R&D workstream, throughout the EU MDR transition, lending support as issues arise
- Provides support and communications applicable to the EU MDR program to ensure business partners are successful in implementation of EU MDR Requirements
- Tracks and communicates sub-stream progress, risks, timelines, etc to team members, sponsors, decision makers and business partners
- Plans and leads kick-off meetings, as required
- Liaise with other EU MDR workstreams, discuss resolution options, remove blockages
- Acting as R&D lead on collaboration on IT on solutions needed for MDR regulations and material management
- Identify items which could impact the EU MDR Program or EO Workstream
- Forecast current and future year business plans (resources and discretionary spend) as well as monitor, manage, and adjust OneMD spend between franchises for work stream
- If and when appropriate, ensure knowledge transfer to J&J team
- A Bachelor’s degree with a minimum of 6 years of relevant work experience is required
- At least 3 years of project coordination or project management experience, preferably in the biotech, pharmaceutical or device industries is preferred
- Technical or engineering degree is preferred
- Project Management certification is preferred
- Experience with R&D processes and procedures is required
- Experience leading cross-functional project teams is required
- Experience within a OneMD R&D business to demonstrate technical acumen during collaboration with businesses is preferred
- Experience with US and EU regulatory systems is preferred
- Multi-functional experience in R&D, QA, Regulatory is preferred
- Strong communication & presentation skills with an ability to interact with cross-functional and remote project teams is required
- Proficient in MS Office (Project, Power Point, Excel, Word) is required
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.
Depuy Orthopaedics. Inc. (6029)