Salary: Highly competitive salary + benefits depending on experience
Evolve Consultant: Claire Handley & Andy Boyd
We have a new opportunity available to join a privately-owned, leading Medical Devices company. Our client is seeking an experienced Compliance Associate to support the Regulatory compliance to relevant regulations and standards globally, and compliance to all other market requirements where applicable.
Key roles and responsibilities for the Compliance Associate
Maintenance of Technical Files and all relevant documentation required to support device to market.
Support transition from MDD to MDR in line with Regulatory Compliance Manager’s transition plan.
Assess product compliance and associated risks; assist in developing risk management strategies.
Develop and maintain proficiency in internal auditing procedures and activities in line with Quality Manager.
Support procedural reviews and updates as required by Regulatory Compliance Manager.
Minimum requirements for the Compliance Associate
You will have strong experience as a Regulatory Affairs or Quality Assurance professional in Medical Devices.
You will have knowledge of regulatory requirements for medical devices including: Medical Device Directive (MDD) 93/94/EEC, ISO 13485 and ISO 14971.
Worked effectively in project teams, with a commitment to meeting team-based deliverables and timelines.
Proficiency in document manipulation using various software packages including, but not limited to, Microsoft Word, Excel, Power Point and Adobe.
2 stage process
If you want to hear more about this role, please send us your CV by clicking 'apply now