Company:
Elastic Ltd
Location: Lancaster
Closing Date: 20/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Regulatory Engineer - Medical Devices - Competitive Salary and Benefits
A rapidly expanding company in Lancaster is seeking a Regulatory Engineer with experience in the Medical Device sector to join their dynamic team.
You will be instrumental in ensuring regulatory compliance across the company's portfolio, helping to bring innovative healthcare solutions to market.
As a Regulatory Engineer, you will compile and update technical documentation, support regulatory submissions, participate in audits with internal and external stakeholders, ensure ongoing compliance with ISO standards, and investigate non-conformities.
Essential experience:
A rapidly expanding company in Lancaster is seeking a Regulatory Engineer with experience in the Medical Device sector to join their dynamic team.
You will be instrumental in ensuring regulatory compliance across the company's portfolio, helping to bring innovative healthcare solutions to market.
As a Regulatory Engineer, you will compile and update technical documentation, support regulatory submissions, participate in audits with internal and external stakeholders, ensure ongoing compliance with ISO standards, and investigate non-conformities.
Essential experience:
- Knowledge of medical device regulations (e.g., ISO 13485)
- Experience with product registrations in global markets
- Regulatory documentation and technical file management
- Prior experience in conducting audits to quality standards
- Hands-on experience in quality management systems (QMS)
- Knowledge of medical air filtration and PPE products
- Prior experience implementing and upholding health and safety standards
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Elastic Ltd
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