- Prepare and submit regulatory documentation, such as technical files, risk assessments, test reports, and declarations of conformity
- Review and oversee testing of medical devices for compliance with ISO60601 and other applicable standards and regulations
- Liaise with regulatory authorities and customers on compliance matters and respond to queries and requests
- Monitor and update compliance policies and procedures in accordance with changes in standards and regulations
- Support Post Market Surveillance activities
- Provide guidance and support to other engineers and departments on compliance requirements and best practices
- Bachelor's degree in life science or engineering, preferably in biomedical, electrical, or mechanical engineering (or equivalent time served)
- At least five years of experience in regulatory compliance for medical devices or other regulated industries
- Working knowledge of CE marking, UKCA marking and other regulatory premarket approvals
- Thorough knowledge of ISO60601 or other equivalent EMC/Safety standards and regulations
- Knowledge of ROHS, REACH and other relevant regulations
- Experience of Quality Management Systems and Risk Management processes
- Excellent communication, analytical, and problem-solving skills
- Ability to work independently and as part of a team
- Attention to detail and accuracy
- Experience in 510(k) or PMA submissions
- Experience of working with clinical trial applications
- Experience in drug delivery devices or robotic and software products
- Experience in MDSAP
- Knowledge of product development documentation for Medical Devices
- Knowledge of ISO 62366, and ISO 14155
- Expertise in Design Control to 13485/21CFR part 820
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Regulatory Compliance Engineer - Charfield, United Kingdom - Renishaw
Description
Job Description
Medical Devices, EMC, Safety
Salary approx. £55-£60k (dependent on experience)
Hybrid working 2 days/week site based with additional days depending on business needs.
We are looking for an experienced regulatory compliance engineer to join our team and help us ensure that our medical devices meet the highest standards of safety and quality. You will be part of a team which is responsible for product approvals and compliance of a number of medical devices including robotic and drug delivery devices. This will include reviewing and overseeing the testing of our products, preparing and submitting regulatory documentation, and liaising with regulatory authorities and customers. You will also provide guidance and support to other engineers and departments on compliance issues and best practices.
To be successful in this role, you should have a bachelor's degree in engineering, preferably in biomedical, electrical, or mechanical engineering (or time served), and at least five years of experience in regulatory compliance and submissions for medical devices or other regulated industry. You should also have a thorough knowledge of ISO60601, the international standard for medical electrical equipment, or other equivalent safety/EMC standards and regulations. You should have excellent communication, analytical, and problem-solving skills, and be able to work independently and as part of a team.
Responsibilities
Key requirements
Desirable requirements
Benefits
When you join Renishaw, we're committing to your future career. That's because we believe in developing our people's skills and promoting them internally. We also offer a benefits package that's highly desirable; including a 9% non-contributory pension, discretionary annual bonus, *subsidised onsite restaurants and *coffee shops, free parking, *car sharing scheme and *24 hour fitness centres. (*not available at our Castle Donington, Exeter, York & Edinburgh sites).
We also want to promote a healthy work-life balance as much as possible, so we have introduced a hybridworking policy which allows for a combination of home and office based working depending on the nature of your role. We also offer a variable working programme, 25 days holiday plus bank holidays, Life Assurance policy of 12 times annual salary, Cycle to Work scheme, enhanced maternity pay subject to qualifying criteria, the option to join BUPA Renishaw health trust and an Employee Assistance Programme for employees and family.
Please click for further information about our benefits.
Please click for further information about diversity and inclusion at Renishaw.
Employment Type:
PermanentTime Type:
Full timeRequisition Number:
R6723 Regulatory Compliance Engineer (Open)
