Logo
MillenniumSoft Inc

EU MDR Program Manager

MillenniumSoft Inc, Warwick, Rhode Island, us, 02888

Save Job

Join to apply for the

EU MDR Program Manager

role at

MillenniumSoft Inc 11 months ago Be among the first 25 applicants Join to apply for the

EU MDR Program Manager

role at

MillenniumSoft Inc Get AI-powered advice on this job and more exclusive features. This role works across all client Surgery functions to lead the transition to new compliance regulations for the European Union (EU),EU MDR and coordinate activities with client synergies and NPD to assure seamless integration. The role will coordinate with multiple functions including R&D, Packaging, Operations, Regulatory and Quality. Knowledge of design control, Restricted Substances, Design Quality, Biocompatibility and Risk Management are required. 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 deliverable within the established program timelines. You will be successful by partnering with EU MDR team members as well as Synergy and NPD program leaders to ensure process/procedures, organizational changes and system updates have been modified and the affect of all programs are considered. This role is a 15-20-month duration based assignment. Responsible for maintaining all active project plans in MS Project (or other similar PPM software) and will be responsible for helping client associates to learn and adopt these technologies.

Position : EU MDR Program Manager

Location : Warwick, RI

Duration : 12 Months Contract

Total Hours/week : 40.00

1st shift

Description

This role works across all client Surgery functions to lead the transition to new compliance regulations for the European Union (EU),EU MDR and coordinate activities with client synergies and NPD to assure seamless integration. The role will coordinate with multiple functions including R&D, Packaging, Operations, Regulatory and Quality. Knowledge of design control, Restricted Substances, Design Quality, Biocompatibility and Risk Management are required. 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 deliverable within the established program timelines. You will be successful by partnering with EU MDR team members as well as Synergy and NPD program leaders to ensure process/procedures, organizational changes and system updates have been modified and the affect of all programs are considered. This role is a 15-20-month duration based assignment. Responsible for maintaining all active project plans in MS Project (or other similar PPM software) and will be responsible for helping client associates to learn and adopt these technologies.

Experience

Must have previous experience as Program Manager in medical device field for a minimum of 7 yrs. in the area of NPD. Extensive experience with US and EU regulatory systems and requirements is essential to the position as well as technical knowledge of operations execution. The role will work across multiple functions in the transition to new compliance regulations for the European Union (EU) and implementation of all requirements at the Business Unit (BU) as well as manufacturing sites. .

Qualificatiions & Skills

Bachelors degree in related field (business, engineering, or related analytical field). 6+ years of project management. History of working in a shared service or BPO organization. Mastery skills in understanding the business, being agile and applying expertise in communication and working with diverse groups of people and skill sets. Mastery of project scheduling skills and use of PPPM software (like MS Project, and Project Server). Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

Job function Project Management and Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x Get notified about new Program Manager jobs in

Warwick, RI . Woonsocket, RI $100,000 - $130,000 2 weeks ago Woonsocket, RI $100,000 - $130,000 2 weeks ago Woonsocket, RI $100,000 - $130,000 1 week ago Bristol, RI $99,000.00 - $128,000.00 2 weeks ago Bristol, RI $99,000.00 - $128,000.00 3 weeks ago Senior Manufacturing Project Manager (L&AS and M&SS)

Pawtucket, RI $114,100.00 - $171,100.00 5 days ago Assistant Program Operations Manager RA101-Full Time/Evenings

East Greenwich, RI $140,000.00 - $170,000.00 3 weeks ago Senior Technical Program Manager - Workday Financial Management (REMOTE)

Providence, RI $130,000 - $260,000 3 days ago Attleboro, MA $104,600 - $143,770 3 weeks ago Program Manager 3 - Tech Sales Practices

Rhode Island, United States $86,770 - $138,850 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr