Our Client, a well established Medical Devices company based on the South Coast are looking for a talented Compliance Engineer who will relish the challenge of taking ownership of this newly created role within the business.
You will play a key part in ensuring the regulatory compliance for new product development and design changes to established legacy devices as the company Manufacture Class IIa and IIb products to UK and EU MDR standards.
- 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
- Hybrid working
- Actively monitoring; seeking to understand and analysing the impact of all new and updated Regulations and standards applicable to the product range.
- 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.
- A formal engineering qualification preferably in electrical/electronic, mechanical, or microbiological/biomechanical engineering, or experience in a similar role preferably within the medical device industry or other highly regulated industry.
- Direct experience of monitoring, interpreting and applying regulatory standards to product designs. Knowledge of relevant regulations applicable to medical devices is desirable, e.g. UK MDR and EU MDR and related standards such as ISO 14971, BS EN 13060 and BS EN 61010.
- 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 and constructive ideas in addressing problems.
- A logical and pragmatic approach coupled with the ability and tenacity to obtain information with minimal 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.
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.