We are currently looking to recruit an experienced Regulatory Compliance Specialist for our highly successful and growing client. This role forms the next part of the company's on-going development, as they continue to grow in 2021.
In this key hire for the company, you will support Regulatory Compliance to relevant regulations and standards globally, and compliance to all other market requirements where applicable. You will support the company's transition from MDD to MDR, and take ownership of Technical Files and associated documentation/activity.
Creation and maintenance of Technical Files and all relevant documentation required to support.
Support transition from MDD to MDR in line with Regulatory Manager's plan.
Assess product compliance and associated risks, and manage the development of risk management strategies.
Develop and maintain proficiency in internal auditing procedures.
Support procedural reviews and updates as required by Regulatory Manager.
Support Quality, Regulatory and Technical departments during external audits.
Identify areas of non-compliance and discuss resolutions with Regulatory Manager to rectify.
Support interactions with Notified Bodies and Competent Authorities.
Regulatory lead on new product introductions as indicated by Technical department priorities.
Control and revision of documentation through electronic document control system
Control and revision of device labelling through electronic labelling systemQualification, Skills & Experience:
Experience as a Regulatory Affairs or Quality Assurance professional in Medical Devices
Particular 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
Excellent communication skills both orally and written
Strong collaborative skills
Proficiency in document manipulation using various software packages including, but not limited to, Microsoft Word, Excel, Power Point and AdobeDesirable:
Understanding of Design Controls as per 21 CFR Part 820.30, and requirements for Design History Files
Awareness of Customer Complaints and Post-Market Surveillance processes
Participation in internal auditing programsOur client offer this position on a permanent basis, with a competitive package (salary circa 32-36k). This comes with excellent benefits and career progression opportunities within a truly globally reaching organisation
Medical Device Directive