Project Manager - Internal
Cary, USA Personal services
Job description
Do you want to join us in helping to fight the world’s mostthreatening diseases and enabling access to care for more people around theworld? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
At Siemens Healthineers, We offer you a flexible and dynamicenvironment with opportunities to go beyond your comfort zone in order to growpersonally and professionally. Sound interesting? Then come and join our globalteam as Project Manager to support theUpdate Management & Field Corrective Action area within Specialty Services.
Our global team: We are ateam of more than 70,000 highly dedicated employees across more than 70countries passionately pushing the boundaries of what’s possible in healthcareto help improve people’s lives around the world. As a leader in the industry,we aspire to create better outcomes and experiences for patients no matterwhere they live or what health issues they are facing. Our portfolio, spanningfrom in-vitro and in-vivo diagnostics to image-guided therapy and innovativecancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are partof an incredible community of scientists, clinicians, developers, researchers,professionals, and skilled specialists pushing the boundaries of what’spossible, to improve people’s lives around the world. We embrace a culture of inclusivity in whichthe power and potential of every individual can be unleashed. We spark ideasthat lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious professional, lookingfor the next step in their career. As a Project Manager, youwill be responsible for
- Facilitatingthe timely completion of FDA Regulated Updates
- Managingthe entire Update Lifecycle Process including Update planning, due dateassignment, material availability and on time completion.
- Simultaneouslymanaging multiple Update revisions/projects at any given time.
- Workingclosely with Product Support Teams/Business Units and Data Management Teams toensure install base accuracy and data integrity for FDA Compliance Reporting
- Workingclosely with Regulatory Affairs to ensure project milestones are defined andachieved according to Industry Regulations outlined in CFR 21 – 806.10.
- Organizing,preparing mails and tracking FDA Regulated Customer Safety Advisory Notices forall patient safety recalls.
- Ensuresproper customer signatures are obtained via electronic tracking and reporting.
- Identifiesand executes project’s implementation strategy in accordance with IndustryRegulations for timely communication of patient safety recalls.
- Workingclosely with Regulatory Affairs to ensure project milestones are defined andachieved according to Industry Regulations outlined in CFR 21-7.46.
- Ensuresdata integrity for accurate assessment of affected systems
- Proactivelyidentifying areas of risk with non-compliance to industry regulations forpatient safety recalls and non-mandatory updates.
- Frequentlyparticipating in unannounced FDA Audits for previously executed projectsrelating to Patient Safety Recalls.
- Provides copies of FDA requesteddocumentation such as Customer Safety Advisory Notices, Electronic Signatures,Customer Refusal Letters, and any other pertinent information related topatient safety recalls and performance updates.
- Managingproject deliverables as part of milestone management such as quota, technicaldocuments and other “soft” deliverables.
- Managingproject milestones to ensure on time completion and identify, withanticipation, actions required to keep them on track, including customermilestones such as proactive scheduling and required room availability forupdate performance.
- Providingstatus updates and escalations to various levels of management when complianceand on time completion are at risk.
- Providingreports on progress and actions on a regular basis by researching, documenting,and presenting findings.
- Maintainingprofessional and courteous communication with internal and external customersto ensure smooth, clear, concise, and timely communication of alltypes.
- Ensurignlabor and travel reimbursements are achieved by monitoring and tracking on timecompletion.
This position may suit you best if you are familiarwith what is below, andwould like to do develop your career with Healthineers
- Able todemonstrate the ability to handle semi-complex to complex projects anddetermine the critical path to improve timely performance
- Knowledgeof SAP a plus but not required
- You havegood PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
- Strongcommunication skills needed, both verbal and written
Requiredskills to have for the success of this role
- Bachelor’sdegree or equivalent Project Management experience required (up to 2 Years)
- Willingto travel up to 5%
- EntryLevel Project Manager position.
HYBRID TO CARY NC
At SiemensHealthineers, we value those who dedicate their energy and passion to a greatercause. Our people make us unique as an employer in the med-tech industry. Whatunites and motivates our global team is the inspiration of our commonpurpose: To innovate for healthcare,building on our remarkable legacy of pioneering ideas that translate into evenbetter healthcare products and services. We recognize that taking ownership ofour work allows both us and the company to grow. We offer you a flexible anddynamic environment and the space to move beyond your comfort zone to grow bothpersonally and professionally.
If youwant to join us in transforming the way healthcare is delivered, visit ourcareer site at https://jobs.siemens-healthineers.com/careers
If youwish to find out more about the specific division before applying, pleasevisit: https://usa.healthcare.siemens.com/about.
Bewareof Job Scams
Pleasebeware of potentially fraudulent job postings or suspicious recruiting activityby persons that are currently posing as Siemens Healthineersrecruiters/employees. These scammers may attempt to collect your confidentialpersonal or financial information. If you are concerned that an offer ofemployment with Siemens Healthineers might be a scam or that the recruiter isnot legitimate, please verify by searching for the posting on the Career site: https://jobs.siemens-healthineers.com/careers
Successfulcandidate must be able to work with controlled technology in accordance with USexport control law.” “It is Siemens Healthineers’ policy to comply fully andcompletely with all United States export control laws and regulations,including those implemented by the Department of Commerce through the ExportAdministration Regulations (EAR), by the Department of State through theInternational Traffic in Arms Regulations (ITAR), and by the TreasuryDepartment through the Office of Foreign Assets Control (OFAC) sanctionsregulations.
· Great Place to Work Certified 2023
· Best Places to Work for LGBTQ Equality
· Best for Vets Employers by Military Times
· Glassdoor Employer Rating: 4.0
As anequal-opportunity employer we are happy to consider applications fromindividuals with disabilities.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
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