Manage the complete project life cycle for healthcare and medical device implementations, including discovery, analysis, estimation, development, quality control, and delivery, in conjunction with product and technical teams
Lead requirements gathering sessions with client business, IT, Regulatory Affairs, and Quality stakeholders to define and document business needs
Create detailed specifications and solution designs, documenting current and future process flows and use cases in partnership with data engineering and development teams
Manage program scope according to client constraints and regulatory requirements
Develop and maintains project plans, including analysis, planning, tracking, reporting, and evaluating milestones and deliverables
Triage incoming issues, determines root cause, and routes them to the appropriate internal team (Product, Support, Services, Engineering) for resolution during implementation
Provide technical support to onsite users regarding workflows, feed failures, and related troubleshooting through go-live
Track issues through to resolution, keeping clients and internal stakeholders informed of status during implementation
Document open items and known issues clearly as part of the handoff package to the ongoing support team
Support customers implementing regulated product data and medical device information across global and regional requirements
Understand and communicates client needs related to regulatory bodies and systems such as EUDAMED, FDA GUDID, other Unique Device Identifier (UDI) data requirements, and adjacent healthcare data standards
Partne with Product and Services teams to translate client regulatory workflows into business requirements, pilots, and process improvements during implementation
Stays current on healthcare regulatory trends relevant to clients and helps internal teams understand their impact
Own client and program team communication throughout the project, coordinating meetings, updates, and historical records of progress
Work with Account Executives to develop and present milestone or go live reviews, highlighting outcomes and risks
Build trusted working relationships with client stakeholders across Regulatory Affairs, Quality, IT, and Operations during the engagement
Lead a structured handoff to the ongoing account or support team, ensuring context, risks, and open items transfer cleanly
Periodic travel to clients and Syndigo offices as needed
Pull and push key performance reporting to clients, providing insight into systemic and people processes
Identify issues, forms hypotheses, executes analysis, and translates data into actionable recommendations throughout the project
Develop executive-level dashboards and business reviews
WE SHOULD TALK IF THIS SOUNDS LIKE YOU
5+ years of experience in project management or a client facing role in SaaS
Excellent analytical, verbal, and written communication skills
Experience working with executive level clients, suppliers, and consultants to gather requirements and execute project plans
Experience supporting Medical Device Manufacturers, Life Sciences organizations, Healthcare Technology providers, Regulatory Affairs teams, Quality Management functions, or Healthcare Data Operations preferred.
Comfort with technology, particularly product information management, data quality, and complex client workflows
Experienced user of Smartsheet, SharePoint, Microsoft Office Suite, including Word, Excel, and PowerPoint Experience with Microsoft Access
Knowledge of Salesforce, Jira, and Wrike
Experience with data governance and maintenance preferred healthcare related experience a plus
Familiarity with healthcare or medical device regulatory data requirements (FDA GUDID, EUDAMED, EU MDR/IVDR, GDSN, SWISSDAMED, TGA AUAUDI) preferred, but not required at entry
Exposure to healthcare, life sciences, or retail industries a plus
BA/BS degree in Computer Science, Business, or a related field preferred
PMP certification preferred
For full-time U.S. based-employees, we offer competitive health insurance benefits, PTO and volunteer time off, employer-paid short- and long-term disability, parental and adoption leave, 401(k), and tuition reimbursement.
Your individual compensation within the budgeted salary range is determined based on your skills, education, experience, and internal equity. This position is Bonus Eligible.
Budgeted Salary Range
€30.000—€35.144,80 EUR
Bonus
€3.000—€3.514,48 EUR
Diversity, Equity & Inclusion
To achieve the best version of our organization, we know it takes new ideas, new approaches, new perspectives and new ways of thinking. A purpose we are 100% committed to cultivating. Diversity is woven into our fabric at Syndigo and it’s how we stay an industry leader, innovating technology solutions that equip our customers with everything they need to be successful!
All are welcome here and we invite you to join our team if you are ready to help us continue that growth!
GDPR/CCPA
Syndigo, to process applications, holds onto data for a "reasonable time" after applications are submitted. This data is stored for Syndigo's internal use by HR/Recruiting Staff only. Verified requests for data deletion and exports will be completed upon request.
Syndigo Job Applicant Privacy Notice
At Syndigo, we care about your privacy. As you go through our recruitment process, we are committed to being transparent about how we process your personal data. To learn more about how Syndigo processes your personal data, go to our Job Applicant Privacy Notice.
