Medical Devices Project Manager
il y a 23 heures
Company Description
At **SGS**, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to _expand_ or to _enrich_? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.
**SGS** is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to almost 100 000 colleagues worldwide, with more than 1850 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise.
**Job Description**:
We are currently looking for a **Medical Devices Project Manager** for the **SGS Notified Body 1639 in Antwerp.**
**Purpose of Role**
A local representative for the Notified Body (NB) for the Medical Device Technical Liaison
Office (MDTLO) covered region covering the following tasks:
- The responsible person for overview and monitoring of local contracts
- To prepare and track the steps to be taken for Change Notifications, pre-audit questionnaires. Incident Notifications sent by customers' by reading the submitted documents, collecting more information if necessary and motivating (by writing) proposed decisions to be taken by the Notified or Certification body.
- To keep an overview of the ongoing certification process and history of customer contracts and be the responsible person (and the contact person) connecting the different shareholders (client, auditors, Product Assessors, clinical reviewer, Global Clinical and Regulatory Affairs Manager, GMD Technical Manager and GMD Certification Manager, )
- Track and report MDTLO KPI and relationship with Delivering Office (DO) monitoring (monthly report)
- To track and report PM KPI’s and liaise with other NB PM’s on order to ensure global PM and resource planning.
- Liaise with the MDTLO partners to establish business needs for each year, including, Y+1 and Y+2
- Keep local overview of competence codes used and needs in collaboration with GMD Technical Manager - Competences. Ensure codes are maintained, follow up expiry dates, follow through re-approvals. Ensure resource planning based on code needs.
**Key Accountabilities**
- Serve a point of first contact between the NB 1639 and the Medical Device Technical Liaison
- PM coordination: Co-develop tools for tracking PM and KPI’s, KPI follow up and reporting, Review of the KPI’s data and suggestions and completion of improvements, Global coordination with other PM’s
- Business development tracking
- Customer relationship: Ensure all communication with customers is in a timely manner and ensure all requests are reviewed/actioned, Follow timelines for execution of contract cycles,
**Qualifications**:
Desirable:
- Knowledge of QMS/Medical Device approval processes
- Certificate of project management skills (e.g. Project Management Professional certificate)
- Previous project management experience, preferable of multiple parallel projects.
- Having developed tools and processes for project management
- Must have or acquire an adequate understanding of the relevant medical device regulations, normative and guidance documents (EU Medical Device Regulations, national legislation, IMDRF, MDCG, CS,..)
Essential
- Minimally Bachelor level with scientific or technical background
- Effective interpersonal skills, able to develop good working relationships with both colleagues and customers
- Willingness to learn and adapt to change - committed to continuous personal and professional development
- Able to follow procedures, rules and best practices applied by NB SGS Belgium n° 1639 and SGG
Additional Information
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