Project Coordinator

2 weeks ago

Southampton, United Kingdom Tellspec LTD Full time

We are seeking a highly motivated **Project Coordinator** to join our team, in Southampton, and help us track and coordinate a team that is working in achieving IVD medical certification or our neonatal medical device. We are looking for someone excited to work on innovative projects with influential partners and organisations so as to continue our work and mission.

**Key Responsibilities And Outcomes**
- Liaise with key stakeholders to identify and define project requirements, scope and objectives ensuring technical feasibility and quality requirements are met
- Work closely with CEO to prepare project execution plans, including resources, timeframes and budgets
- Develop and manage a detailed project schedule and day to day plans
- Maintain and monitor project progress ensuring project deadlines are met
- Facilitate an agile yet realistic approach to management of any changes
- Oversee project procurement management
- Manage subcontracted engineering services
- Work closely with the project team and technical leads to identify and eliminate showstoppers
- Use tools to monitor working hours and expenditures
- Support the development and implementation of Project Processes
- Ensure that all projects deliver agreed outcomes on-time, within scope and budget
- Report progress and escalate to CEO as needed
- Liaising regularly with internal and external stakeholders, including attending, organising and leading meetings, representing the company’s perspective at project meetings to facilitate successful project development

**Requirements**:
To be successful in this role you should have a combination of the below knowledge, skills, and experience:

- 5+ years experience as a Project Manager or similar role
- Bachelor’s degree in biomedical, health or engineering sciences
- Experience of working in research management, technology transfer environment, health tech accelerators, start-ups and/or organisations supporting innovation
- Experience of supporting the financial aspects of projects and financial procedures.
- Proven experience in managing subcontractors
- Experience with managing Innovate UK grant funded projects
- Understanding of intellectual property and commercial aspects in relation to research commercialisation
- Committed team player
- Excellent written and verbal communication skills.
- Excellent analytical and problem-solving skills
- Ability to effectively manage risks and issues as they arise
- Experience in leading projects from concept to through scale up and deployment
- Strong organisational skills, including multitasking and time-management
- Hands-on experience with project management tools
- Ability to work independently and as part of a team
- Ability to produce high quality documentation using Microsoft Office

**Responsibilities**
Manage submissions and other regulatory aspects during the development phase of our medical device, including but not limited to Clinical Trial Applications, Neonatal Investigational Plans, Scientific Advice in the UK.
Manage both centralised and/or decentralised submissions for approval and maintenance of marketing authorisations for our device in the UK.
To develop regulatory strategies during development, approval and post approval phases for submissions to UK Competent Authorities.
To obtain regulatory approvals and other feed-back or decisions from UK Authorities during further development of our device.
To obtain registrations for innovative medical devices, in the UK and to ensure that the registrations for existing marketed products are maintained.
To provide regulatory guidance to cross-functional teams.

**Requirements**:
Substantial UK regulatory affairs experience (at least 5 yrs), preferably with experience also in the EU.
Experience in managing development work, new submissions and maintenance work will be a distinct advantage.
Experience with relevant medical device related aspects in the neonatal setting.
Innovative Medicine experience in the neonatal nutrition area is also a significant advantage.

**Key Accountabilities**
- Conduct audits at clients’ sites and remotely, in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
- Work alone or lead audit teams as appropriate, enhance client satisfaction and ensure compliance with standards and regulatory requirements
- Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
- Be a Final Reviewer and Certification decision maker for IVD audits.
- Develop and maintain strategic growth plans for IVD services, working with the Head of Sales and Marketing, Operations managers and Academy Manager to ensure all aspects of the customer journey are covered.
- Support UKCA Medical devices Certification Manager with technical and procedural requirements for IVD UKCA certification to ensure SGS compliance and participate in Regulatory Body a

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