- Plasterers Penryn
- RecruitEasy in Penryn, , United Kingdom
- jobs
- 3 weeks ago
jobs description
Our client a global Medical Device manufacturing company specialising in Fem Tech are looking for a Regulatory Affairs Manager to join an exiting team reporting to the Director of Regulatory Affairs. The company produce equipment, consumable medical devices and general laboratory equipment. A cross functional role the chosen candidate will work with internal and international teams/departments.T...he company will offer hybrid or remote working for those further away if needed.Summary:The Regulatory Affairs Manager is responsible for regulatory strategy to attain and maintaining EU, US and UK device certifications and market clearanceregulatory assessment of changes to devices, process, supply chain and regulations, and resultant notification and re-registration activitiesproactively monitoring changes in EU and UK medical device regulations, and share or provide training to global Regulatory Affairs teams, commercial, distribution and service teamsUKCA mark compliance and MHRA registration and listingSkills:Management, support and development of RA team members responsible for creation and maintenance of Technical Documentation Files, Device History FilesThe Regulatory Affairs Manager will be managing RA projects and define strategy for new product development, maintenance of legacy device portfolio, acquisitions, etc.Proactively monitor changes in regulations and share or provide training Regulatory Affairs teams, commercial, distribution and service teamsManage the creation and maintenance of Technical Documentation FilesEnsure effective project management for product certification, registration and re-registrationRA strategic planning and assessmentsRegulatory representative and advisor for new product development at concept phaseDevelop business relationship with key stakeholders (internal/external)Achieve measurable results in all certifications and ongoing submissionsThe Regulatory Affairs Manager will participate in training and attend conferences, and meetingsProvide regulatory support during surveillance audits as necessary to maintain international licenses, registrations and certificationLead Regulatory support for closure of non-conformances raised at internal or external auditsRegulatory Lead for QMS documentation, change control, and design and process deviation managementRegulatory Lead point contact for global vigilance, FSCAs and recallsQualificationsKnowledge of medical device requirements primarily for US and EU marketsAbility to read and interpret medical device regulations and requirementIdeally Degree in Life Science, Engineering, Compliance etc. OR equivalent practical expertiseTo find out more about Real, please visit
Penryn United Kingdom