£60000 - £70000 per annum
8 months ago
£60,000 - £70,000 per annum + benefits
Wokingham based with flex to work from home
A global leading US based organisation specialising in the medical devices manucfactruing supply of O2 concentrators and liquid O2 concentrators are seeking an experienced regulatory specialist to lead EU efforts for Quality and Regulatory.
This role will involve around 20% travel to sites in the EU including Italy, Germany. You will also be required to travel customer sites when completing audits couple of times per year.
Job outline - Regulatory Specialist:
The Regulatory & Quality Specialist will be a key member of the Regulatory Affairs team who will provide regulatory support and expertise to maintain compliance with European medical device regulations and also work with the global regulatory team on global registration and compliance activities.
Ensure product/process compliance with the requirements of ISO 13485, MDD/MDR, TPED, FDA etc.
Manage and maintain the Quality Management System for Europe-based facilities
Assist in the review and implementation of internal quality/regulatory procedures to ensure regulatory compliance is maintained or enhanced
Lead the initial effort to secure the required product approvals including document submissions to regulatory authorities and notified bodies.
Work with Engineering on new product releases and changes to develop Regulatory Plans including required testing, approvals, labelling and post market reporting.
Manage and maintain regulatory files based on regulatory (e.g. MDD, MDR, TPED, etc.) and post-market requirements
Work with Design and Development Project teams to ensure compliance with Design Control Requirements.
Lead training in the European and UK facilities to ensure personnel are familiar with and knowledgeable regarding regulatory and associated reporting requirements.
Assist with European Vigilance activities and coordinate associated testing with technical service
Participate in external and internal audits
Experience required - Regulatory Specialist:
Must have worked in a medical device regulatory environment with knowledge of ISO13485, MDD.
Experience with various Codes and Standards (ISO 13485, MDD, TPED, FDA, PED, etc.)
Working knowledge of EU MDR (2017/745) and MHRA regulations is desirable
Experience and working knowledge with international product approvals.
Excellent communication skills at all levels (written and verbal)
Package- Regulatory Specialist:
£60,000 - £70,000 per annum.
30 days holiday
37 hours per week - Mon - Fri