Compliance Engineer
4 days ago
Great Staff Benefits ie Cycle to work
- Excellent Company
- £Competitive
Here at TPA we are very excited to be able offer the position of Compliance Engineer with a highly competitive salary and desirable staff benefits.
Based in Lancing
The Role
We believe that every individual can make a big difference, and we are currently looking for a Compliance Engineer to join our growing team and make that difference.
The Compliance Engineer will assist the Product Development & Engineering Support Manager in ensuring the regulatory compliance to medical device regulations for new product development and design changes to established legacy devices.
Main duties include;
- Actively monitoring; seeking to understand and analysing the impact of all new and updated Regulations and standards applicable to our products.
- Managing the standards compliance process including, when necessary, performing a gap analysis and technical review of a new or updated standard and the generation of an action plan that will ensure continued compliance.
- Ensuring the actions from the above plan are carried out by suitably qualified personnel, arranging external testing where necessary, scheduling internal testing and, where appropriate, carrying out the required testing.
- Collaborating with Regulatory Affairs to understand existing, new and planned changes to regulatory requirements/guidelines and standards and they relate to company products and procedures.
- Assisting with the generation of the Systems Requirements Specifications (SRS) to ensure requirements are complete and testable.
- Ensuring procedures related to product compliance are maintained and followed.
About You
- A formal engineering qualification preferably in either electrical/electronic or mechanical engineering, or similar and significant experience in a similar role preferably within the medical device industry.
- Knowledge of relevant regulations applicable to medical devices, e.g. UK MDR and EU MDR and related standards such as ISO 14971, BS EN 13060 and BS EN 61010 is desirable.
- Innovative and creative with regards to identifying solutions to problems and improving existing systems and processes.
- Ability to provide clear, concise and comprehensive verbal and written reports to all levels within the Company and third parties. Ability to liaise and negotiate with others in the pursuit of goals. Must be able to work with others, providing support andconstructive ideas in addressing problems.
- A logical and pragmatic approach coupled with the ability and tenacity to obtain information with mínimal supervision is essential. Strong ability to influence and motivate people, having good business sense coupled with mature and tactful approach.
- Self-motivated and well organised, flexible and adaptable with excellent planning and organisational skills.
- Computer literate.
Our Story
British design and manufacturing business providing medical, dental and animal health products and services to clinical professionals and organisations around the world, and we are proud of our history and heritage.
First established in 1830 and starting out in surgical instruments, we went on to use our experience to manufacture operating theatre tables, electrosurgery, surgical suction units and autoclaves. Today, we are proud to manufacture autoclaves and surgical suctiondevices which are used across a wide range of sectors including: healthcare, dental health, animal health and workplace solutions.
We have long recognised that it is the people who make us who we are and help us to make the difference. We operate with a team of over 40 trained engineers across the UK, supported by our team based out of our Lancing Office, guaranteeing you can always relyon us to provide high quality products as well as an unrivalled level of service.
For You
We're passionate in seeking ambitious, talented and motivated individuals at every stage of their career, and in addition to the standard statutory benefits, will provide them with the following:
- 25 days annual leave plus bank holidays
- Cycle2work scheme
- Money back on everyday health costs including optical, dental and other therapies
- Training and development support
- Retail and health club discounts
- Access to a 24-hour advice and Information line for you and your family covering legal, health and wellbeing advice
- Life Assurance
- Company sick pay scheme
Being an SME you will also have the opportunity for contact with senior leaders. We can also provide you with a positive workplace culture including hybrid working, following a successful training period.
Location and transport
Based in Lancing, West Sussex on the sunny South coast, we have on-site parking for those using 4 wheels, Lancing Station is a 20-minute walk for those requiring train services, the nearest bus stop is a 5-minute walk, and for those wishing to use 2 wheels,bike storage and on site shower facilities are available.
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