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Product Development Manager
Role Overview
This new Project Manager role will not only manage the project, but motivate the multi-disciplinary team, oversee all planning and assess all project timelines. They will be responsible for ensuring that we comply with ISO 13485; ISO 14971:2019; IEC 62366-1:2015; FDA 21 CFR Part 820; In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), while completing the project on time, on budget and within the outlined scope. This role is based on-site in our UK office with flexible working arrangements negotiable.
Role Requirements
Main Duties:
Provide high level management and direction to the team.
Manage all stages of the project in compliance with design control procedures, in accordance with the relevant regulations.
Develop project plans, budget estimations, set schedules and identify milestones.
Identify, communicate and mitigate project risks and dependencies.
Work closely with the Steering Committee to ensure the project aligns with company goals.
Co-ordinate internal and external resources to ensure that the project adheres to the scope, schedule and budget.
Establish and maintain relationships with relevant internal and external development teams.
Present project updates to the Steering Committee.
Resolve any issues that arise in a timely manner.
Liaise with relevant departments to develop cross functional harmonious working relations.
Person Specifications
Essential Criteria:
BSc in Microbiology or equivalent or a minimum 3 years’ experience working with lateral flow/immunoassay assay development or equivalent In Vitro diagnostic
Experience working in a regulated environment
Proven Project Management track record
Strong technical leadership capabilities
Ability to lead a highly engaged team
Excellent communication and interpersonal skills
High self-motivation and positive attitude
Effective time management skills
Desirable Criteria:
MSc in Microbiology or equivalent.
Experience developing products through IVDR/FDA regulatory pathways
Package
£60,000 – £80,000 basic