R&D Clinical Co-op

Stryker; Belfast; On-site; GBP 25,000 - 35,000; Full time

Job summary

A global medical technology company in Belfast is seeking a full-time support team member for pre-clinical and usability testing. You will handle document management and assist with regulatory submissions related to cardiovascular medical devices. Candidates should possess relevant ongoing degree studies and have knowledge of cardiovascular anatomy. Excellent communication and analytical skills are necessary. This is a full-time position with no travel requirements.

Qualifications

• Prior experience in pre-clinical and usability testing is preferred.
• Strong understanding of cardiovascular anatomy and physiology.
• Familiarity with medical devices, especially cardiovascular ones.

Responsibilities

• Support activities within the clinical department for pre-clinical testing.
• Manage documentation for clinical submissions and regulatory compliance.
• Assist in training industrial placement students.

Skills

Laboratory Experience

Vendor Management

Design Controls

C / C++

FDA Regulations

Intellectual Property Law

ISO 13485

Research Experience

SolidWorks

Research & Development

Internet Of Things

Product Development

Education

Relevant on-going degree course

Relevant A-levels or equivalent

Tools

Microsoft Office

MS Project

Adobe Acrobat

Job description

Work Flexibility : Not available

Provide support for pre-clinical clinical and usability testing activities within the clinical dept. The team member will provide support in document management data management and analysis. The team member will also support other functions such as regulatory quality and post-market clinical follow up data management of clinical and pre-clinical data including the creation of data management in execution of pre-clinical data processing in data recording during usability and pre-clinical with engineering documentation for clinical regulatory submissions and in initial Bench / Pilot testing and writing or review of technical reports in planning pre-clinical and usability studies including equipment sourcing and preparation of data recording with the training officer and assisting in the training of industrial placement students; in the preparation and organisation of stakeholder and advisory and updating documentation in accordance with ISO 13485 GLP and ISO 14155

Qualifications

• Relevant on-going degree course with acceptable 1st year results
• Relevant A-levels of equivalent

Specific Knowledge

• Knowledge and understanding of cardiovascular anatomy and physiology
• Knowledge of medical devices particularly cardiovascular
• Knowledge or experience of general electronics hardware would be useful

System / Computer Requirements

• Basic Microsoft Office MS Project Adobe Acrobat
• Ability to utilise publication search

Competencies needed for this position

• Excellent communication skills (both written and verbal)
• Problem solving and analytical skills
• Technical writing skills
• Time management skills
• High standard of work and strong attention to detail
• Good teamwork skills and ability to work as part of a multi-disciplinary team
• Ability to work under pressure against tight deadlines
• Demonstrate initiative

Travel Percentage : None

Employment Type : Full-Time

Experience : years

Vacancy : 1

Key Skills

• Laboratory Experience
• Vendor Management
• Design Controls
• C / C++
• FDA Regulations
• Intellectual Property Law
• ISO 13485
• Research Experience
• SolidWorks
• Research & Development
• Internet Of Things
• Product Development