REMOTE WORKING - Director/Head of Regulatory Affairs & Quality
- Recruiter
- Turner Regulatory
- Location
-
London
South East EnglandUnited Kingdom
- Salary
- Competitive
- Posted
- 05 Dec 2022
- Closes
- 10 Dec 2022
- Job Title
- Associate Director
- Category
- Public Sector
- Contract Type
- Permanent
- Hours
- Full Time
Remote Working – Director/Head of Regulatory Affairs, Quality, Validation and Health & Safety – Medical Devices The role requires an individual who is a Leader, and is adept in multi–tasking, excellent influencing and negotiating skills. In addition, the candidate will possess the ability to analyse and interpret complex issues and develop effective strategies. Class II and III Medical Devices. Leadership of 3 teams totalling 14+ staff over 3 regions. Full Regulatory pipeline in addition to Quality and Validation. Responsible for all Regulatory and Quality Compliance issues. The candidate will be responsible for representing Regulatory Affairs and ensuring compliance to the highest standards, particularly the EU MDR EU) 2017/745) and FDA QSR (21CFR820), and as defined in Article 15 of the Medical Device Regulation, in addition to similar Regulation in Asia: Manufacturing of Devices. Responsibility for ensuring that reporting obligations are fulfilled and responsibility for all internal and external Regulatory Audits and audits of key suppliers. The candidate must have a proven experience of taking a new Medical Device through Clinical Trials and to Market in the EU/UK and the USA. Proven experience in the Radiotherapy Medical Device Industry. This is an excellent role for a senior Regulatory Affairs professional within Medical Devices. This role would suit a top–end Regulatory Director or Senior Regulatory Director. This company is involved in innovative Products – Proton Therapy specialists. Formulation of robust strategies for implementation regarding any changes to documentation. Working for a Medical Device Company focused on Class II and III Medical Devices, you will be concentrating on products from pre–clinical, through clinical trials to Registration and Post Marketing. CE Marking and good working knowledge of the European Medical Device Directive. 510(K). RAPs RAC Certification or equivalent experience. ISO13485 & 60601; Auditor's qualification preferably for Radiotherapy Medical Devices. Proficient knowledge of Medical Device regulations (21CFR), FDA law, MDR, other global laws and regulations and standards. A university degree in a relevant subject (Law; Physics; Engineering; Medicine) At least eight years of senior professional experience in Regulatory Affairs relating to complex Medical Devices of Class II or Class III Strong background in design controls of Medical Devices. Experience in supporting International Registration and/or Clinical Investigation Geographic scope for this role will be initially UK/EU and USA; further territories including China will be a focus. A superb package is offered: GBP130,000–GBP150,000 basic, bonus/RSU's and leading benefits. The Head Office is in Central London; however, this role can operate with Remote or Hybrid Working. If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on / ; , or , or submit an application by clicking Apply Now.