Salary: Highly competitive salary + benefits depending on experience
Evolve Consultant: Claire Handley & Andy Boyd
Ref: Andy Boyd
Evolve is recruiting for a privately-owned, leading Medical Devices organisation. Our client is looking for a Senior Compliance Specialist to help the Company and related subsidiaries/entities to meet the regulatory requirements of the medical device industry by leading compliance initiatives within the business, ensuring Group operating procedures are implemented throughout the business on a day-to-day basis and compliance to other regulatory requirements as directed by the Regulatory Compliance Manager.
Key roles and responsibilities for the Senior Compliance Specialist
Develop and sustain control and compliance initiatives to evolve controls frameworks, risk management and operational efficiency throughout the Group.
Examples of this would be the review, improvement and maintenance of Change Control process, as well as review and improvement of the Usability process in accordance with internal SOPs, IEC 62366 and HE 75.
Support process reviews and updates as required by Regulatory Compliance Manager.
Provide guidance on the integration of internal controls into regulatory processes and systems to senior management.
Support Design Control process in accordance with internal SOPs and 21 CFR Part 820.30, supporting the Technical department in implementation and maintenance of DHFs.
Minimum requirements for the Senior Compliance Specialist
You will have strong experience as a Regulatory Affairs or Quality Assurance professional in Medical Devices.
Minimum of 3 years in Medical Devices in Quality, Regulatory or Technical role.
You will have experience within a compliance role in Medical Devices or a similar industry.
Experience with SOPs and process improvement is required.
Particular knowledge of regulatory requirements for medical devices including: Medical Device Directive (MDD) 93/42/EEC, ISO 13485 and ISO 14971, Medical Device Regulation (MDR) 2017/745.
Educated to degree level in a Science, Engineering or similar subject.
2 stage process
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