One of the top ten global medical device manufacturers specialising in high-end instruments and implants for emergency and elective surgery. Consistently ranked as one of the best companies in the world to work for market-leading pay and benefits and a strong internal culture.
Responsible for obtaining inputs for projects, creating a project plan, ensuring team members adhere to project timelines, updating project plans, holding or attending team meetings and reporting of project statuses on a weekly basis.
The Project Manager will be responsible for the following activities:
- Understanding the project scope, requirements and overall objectives for EU-MDR
- Creating a change proposal and programme plan
- Taking inputs from relevant SMEs to create a project plan with timelines and milestones
- Holding weekly project team meetings and project reviews
- Reporting on project status on a weekly basis to the Senior Manager RA/QA for EU-MDR
- Ensuring adherence to and communication of timelines to all stakeholders
- Ensuring delivery of project outputs in a timely manner relating to EU-MDR Supporting overall delivery of quality objectives
You, your background -
- Engineering or Science or an equivalent qualification
- Experience in a regulated industry and relevant project management experience
Also do you have knowledge of….
- An understanding of ISO 13485: 2016
- Knowledge of 21 CFR part 820
- Knowledge of ISO 14971 and ISO 14155 would be advantageous
- Project Management
- Regulated Industry
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