Project Manager

Project Manager

Hart Biologicals is engaged in the research, development, manufacture, sale and marketing of a range of "in-vitro" diagnostic products for use in the detection, prevention, and monitoring of a number of medical conditions related to haemostasis and platelet function. The company provides innovative and quality medical products to meet the needs of an ever-changing healthcare field. Hart Biologicals employs 46 people and is located in the North East of England in Hartlepool.

Primary Responsibilities

· Support delivery of a successful Project on time, within budget, and within scope by working closely with Project management, senior management, Technical and Quality dept. teams and external partners on compliance and delivery of contractual milestones.

· Ensure that all deliverables including routine reports are prepared accurately and delivered in a routine fashion to maintain compliance and contractual obligations.

· Work with Project members, and the appropriate technical/quality/regulatory management on requests for subcontractor approval preparation, contract negotiation, contract administration, and customer contact activities to provide for proper contract acquisition and fulfilment in accordance with company policies, legal requirements, and customer specifications.

· Clear project structure, project planning and progress monitoring optimised for a R&D environment.

· Support Project Management to identify and resolve cross-functional issues affecting the Project.

· Support Project Management and members in overseeing risk identification and mitigations.

· Support Project Management and the team in the production of regular financial management documentation and coordination of communications required by the Project progress and contractual compliance.

· Provide project management support on assigned activities across the development of new product.

Required Qualification and Experience

Education:

Degree in Life Sciences, Engineering or Business with solid project administration or management experience, ideally in regulated products development – medical devices and In-vitro diagnostics

Skills:

Proficient in the use of Project software and core Office 365 software (Excel, Word, PowerPoint etc.)

Excellent interpersonal and communication skills.

Ability to build effective relationships across organizational boundaries in order to foster collaboration.

Highly motivated and delivery driven.

Project/program management qualifications such as PRINCE2 or PM

Experience:

You will ideally have experience in the early stages of the product development cycle (e.g., up to CE mark for products which incorporate new technologies towards medical or scientific markets).

Understanding of the requirements of quality systems and regulatory requirements relevant to medical devices e.g., ISO13485, FDA 510(k), and CE IVDR

Benefits:

· Company operates on a flexible working time system.

· Company Healthcare Scheme.

· Auto-enrolment Pension Scheme

As a member of the Equality Register, Hart Biologicals is an equal opportunities employer and welcomes applications from all communities.

Please visit the careers section of our website www.hartbio.co.uk to review our recruitment privacy policy.

Applications to HR Dept., CV & covering letter

Closing date: Tuesday 28th February, 2023

Job Type: Full-time, Permanent position. 37.5hrs p/w

Job Types: Full-time, Permanent

Salary: £40,000.00-£50,000.00 per year

Benefits:

• Company events
• Company pension
• Cycle to work scheme
• Flexitime
• On-site parking
• Private medical insurance

Schedule:

• Flexitime
• Monday to Friday

Work Location: One location

Application deadline: 28/02/2023