An exciting opportunity has arisen for a Technical Documentation Specialist to join our thriving UK medical manufacturing company to work within our expanding Regulatory Department.
We are looking to recruit a Technical Documentation Specialist who will be responsible for compilation and updates of technical documentation files to demonstrate conformity to essential requirements per Medical Device Directive 93/42/EEC and general safety and performance requirements per Medical Device Regulation 2017/745, to ensure compliance to medical device regulations.
You will be working as a part of the team and will be required to prioritise, multi-task and work in a fast-paced environment.
Working as an integral part of the regulatory team, this is a fantastic opportunity for an individual with some experience of working in the medical device industry, to enhance their career as a documentation specialist focusing on technical documentation files.
Technical Documentation Specialist Requirements:
- Excellent organisational skills, with great attention to detail and solution-oriented approach.
- Excellent oral and written communication skills, including the ability to communicate with a number of departments and sites.
- Ability to follow procedures and work instructions to perform tasks and ability to improve work processes and workflows.
- Computer literate with knowledge of Microsoft Office Suite and Adobe.
- Office experience and exposure to various documentation management systems.
- Versatile and adaptable, able to operate under pressure and work on own initiative.
- Bachelor’s degree and / or equivalent experience.
- Candidates with experience of document control and an understanding of ISO standards and design control.
- Experience of work in medical device industry with exposure to Medical Device Directive 93/42/EEC and / or Medical Device Regulation 2017/745.
About Intersurgical Limited:
Intersurgical was formed in 1982 in the UK and started with a modest range of respiratory products. Since its inception, the company has continued to grow and develop and today is the respiratory care specialist in airway management, anaesthesia, critical care and oxygen & aerosol therapy.
The company was formed with seven people, producing a limited product range for the UK hospital market. Today, we employ over 3500 people, producing an extensive product range sold worldwide. We operate across five manufacturing sites and have direct sales operations in over 25 countries and a number of export offices located throughout the world supporting our network of speciality distributors.
Through a constant programme of new product and market development Intersurgical is today one of the market leaders for high quality respiratory care products for the hospital sector worldwide.
Our products are seen as easy to use, technically superior and of the highest quality. The product range is innovative and we will continue to develop and implement improvements.
Location: Head Office (Wokingham UK)
Hours of Work: Monday to Friday. 40 Hours - Flexibility with COVID (i.e. working from home, flexible working hours)
Benefits: Family feel company. Flexible working hours. Training and progression opportunities. Annual performance and salary review. 22 Days holiday increasing with length of service. Subsidised gym membership. Matched pension contributions with length of service. Cycle to Work Scheme.
Closing date: 11-02-2021
You may have experience of the following: Document Controller, ISO Standards, Document Management, Medical Devices, Product Standards, Technical Documentation Specialist, Regulatory Affairs, etc.