Join to apply for the Clinical Regulatory Lead role at BSIJoin to apply for the Clinical Regulatory Lead role at BSIGreat that you're thinking about a career with BSI!Job title :
Clinical Regulatory Lead - ACTIVE DEVICESReports to :
Associate Head of Clinical ComplianceLocation :
home based in - UK, Spain, Germany Ireland, Netherlands, Italy, FranceBSI are unable to provide relocation or visa sponsorship for this vacancy.Due to internal progression we are looking for a Clinical Regulatory Lead with a specialism in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team;
This role will be focused around clinical regulatory support to the operational teams and internal clinicians of BSI, and requires an in depth experience and knowledge of regulatory requirements of active medical devices. The successful applicant will support certificate recommendations by providing strong comprehensive working knowledge of the clinical aspects of the regulations, relevant guidance and appropriate standards.Further DutiesProvide input and expertise related to competence and certification.Monitoring of competence throughout the clinical oversight process by internal auditing.Deliver and Support the delivery of audits of medical devices to maintain awareness of BSI’s systems, and deal with escalated queries.Support process & procedures to be a fully compliant Certification / Notified Body with no systematic non-conformities at audit.Provide Medical device expertise leadership and mentoring for existing and new Global Schemes.Provide advice and support to Global Heads, Product Specialists and Scheme Managers.Support the work of the broader team & training lead in developing and delivering Medical Devices’ internal & external training materials, ensuring up to date and accurate knowledge of regulatory changes & amendments.The Successful Applicant Will HaveStrong experience and knowledge of the regulatory and compliance requirements of active medical devicesA degree or higher degree in medicine, nursing, biomedical sciences, biostatistics or related disciplineBroad clinical and technical understanding of client industry productsA good understanding of Medical Devices Regulations and related guidance and standardsUnderstanding of clinical evaluation processes, data analysis, clinical study designDo you believe the world deserves excellence?As the leading global business standards company BSI helps 80,000 clients worldwide to improve their businesses. From business continuity to recycling waste, from medical devices to the exploration of space, we help businesses embed the habits of excellence so that they perform better, manage their risks more effectively and achieve sustainable growth and in doing so we touch the lives of many across the globe.As a team member at BSI, you will enjoy an extensive, competitive total rewards package. This includes annual leave, bank holidays, learning & development opportunities, and a wide range of flexible benefits that you can tailer to suit your lifestyle.Our Excellence Behaviours :
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.D&I PolicyBSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.If you require any reasonable accommodations to be made on account of a disability orimpairment throughout out our recruiting process,please inform your Talent Acquisition Partner.Our Excellence Behaviours :
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionHealth Care ProviderProfessional ServicesReferrals increase your chances of interviewing at BSI by 2xSign in to set job alerts for “Clinical Lead” roles.Madrid, Community of Madrid, Spain 2 weeks agoGlobal Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)Madrid, Community of Madrid, Spain 6 days agoAssociate Project Manager, Early Phase (Spain)Madrid, Community of Madrid, Spain 4 days agoSenior Director Medical & Clinical Affairs EMEA-LATAMGlobal Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)Madrid, Community of Madrid, Spain 1 week agoBarcelona, Catalonia, Spain 49 minutes agoMadrid, Community of Madrid, Spain 50 minutes agoSr Clinical Project Manager, Europe -RWE / Late PhaseIbiza, Balearic Islands, Spain 50 minutes agoTarragona, Catalonia, Spain 50 minutes agoOviedo, Principality of Asturias, Spain 50 minutes agoValladolid, Castilla and Leon, Spain 50 minutes agoDirector, Medical Strategy Lead - Endocrinologist, ObesityMadrid, Community of Madrid, Spain 2 weeks agoSalamanca, Castilla and Leon, Spain 49 minutes agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.J-18808-LjbffrJ-18808-Ljbffr
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