Job Description

Product Development Project Lead

Full time, remote, permanent position

(Serosep UK offices located in Crawley UK)

Reporting to the Product Development Manager

The Project Lead will be responsible for planning, organising and leading the completion of immunodiagnostic development projects, while ensuring the project is compliant with relevant regulations and standards, completed on time and within the outlined scope.

Main Duties:

Act as point of contact between the team and external partners for Development of assays

Lead all stages of the project in compliance with design control procedures, in accordance with all relevant standards

Develop project plans and identify milestones.

Identify, communicate and mitigate project risks and dependencies.

Work closely with the Product Development Manager to ensure the project is aligned with company goals.

Communicate and provide direction to all external providers working on the project.

Liaise with internal and external resources to ensure that the project adheres to scope and schedule.

Establish and maintain relationships with relevant internal and external development teams, providing up to date information on project status and changes.

Present project updates as required to internal and external stakeholders.

Ensure Project Design History Files and Technical files are maintained to the relevant standards.

Maintain all required Quality documents for the Product Development group e.g. SOPs

Assume individual responsibility for own deliverables and deadlines and collective responsibility for successful on-time completion of the project.

Essential Criteria:

BSc in Life Science or equivalent.

Experience working in a regulated environment

Strong communication and interpersonal skills.

High self-motivation and positive attitude.

Ability to work independently, prioritise and work within a team environment

Experience with ISO13485 and/or 21CFR

Understanding of ISO 14971

Desirable Criteria:

MSc in Life Science or equivalent.

Experience with IEC62366, ISO20916 or ISO62304[CB1]

Project Management experience

Quality system documentation writing experience

Job Type: Full-time

Benefits:

Company pension Work from home
Work Location: Remote