Role: PM Med-Device Vigilance
Term: 12 months
Salary: €100 – 130k
We are excited here at Hays to share that our Client’s Global Health Authority Reporting team is looking for a Project Manager to support implementation of Medical Device Regulations changes within Europe.
The successful applicant will work on critical business projects connecting across multiple businesses and across multiple functional groups to shape the future of Medical Device Vigilance.
Project work will be multi-faceted, focusing on Medical Device Vigilance and Eudamed UKCA, Swiss MedDO regulation changes across multiple MEDTECH divisions.
The PM will be a trusted partner to the company’s Senior Leadership team. The PM will be instrumental in ensuring project success by being able to easily pivot focus from one action to another without losing attention to detail.
Understanding/experience of Complaint Management and Medical Device Vigilance will be necessary to be successful in this role.
Key Responsibilities of the PM:
- Develop a coordinated plan to advance strategic projects in alignment with internal and external stakeholders.
- Ensure development and attainment of project objectives, along with defining success measures.
- Implement a governance structure and actively engage and communicate with executive sponsors and key partners, developing regular communications.
- Lead interdependencies and ensure integration with EUDAMED, UKCA and Swiss MDO teams' objectives.
- Drive risk identification, management and plans for resolution for Vigilance Process.
- Drive robust Change & Communication strategies for strategic priority objectives.
- Lead team meetings, with accountability for agenda & content management.
Experience & skills required:
Background in Quality/ Compliance, Complaint Management and/or Health Authority Reporting. You will also have extensive experience working cross-functionally to achieve goals and influencing without direct authority.
- A minimum of a bachelor's degree or appropriate business experience is required.
- Broad experience and knowledge of world-wide quality system regulations (e.g., MDR (Medical Device Regulation) EU 2017/745, FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements
- Highly skilled at people leadership and organizational change is required.
- Confirmed ability to get results through leading others, organizing, prioritizing, and delegating workload is required.
- Communicating complex ideas in an uncomplicated way is essential for this position.
- Ability to foster team efficiency, cohesiveness, and work collaboratively in a complex environment with multiple, and demanding partners is required.
- Outstanding ability to collaborate to build and implement strategies and drive decision-making is required.
- Excellent verbal and written communication skills are required.
PMP, FPX, Lean/Six Sigma are preferred.
If you are interested in this role contact Hays Recruitment today!!