Head of Regulatory Affairs and Quality Assurance

2 weeks ago

Mendip, United Kingdom Guided Solutions Full time

Our client is a clinical-stage R&D company that is developing an innovative treatment for solid tumour oncology. We are looking for an experienced medical device Regulatory Affairs and Quality Assurance (QA) professional to join the team in this executive role. The role manages the QA Director and reports to the CEO of the company.PLEASE NOTE the role is remote but the company is based in Milan, Italy and travel will be required.Key responsibilities:Responsible for the regulatory strategies and submissions necessary to obtain regulatory clearance and/or approval.Coordinate the implementation and maintenance of the company’s quality management system (QMS).Support project teams during the development of new products and the product lifecycle providing guidance on the applicable regulatory requirements.Prepare or review technical documentation.Represent the company in regulatory, quality, scientific and investor meetings.To be considered for the role, you must closely match the following criteria:A degree in a medical or scientific discipline (biology is preferred).Solid experience in Regulatory Affairs and Quality Assurance of class III implantable and/or combination medical devices.Experience in leading RA/QA activities at a pre-clinical (essential) and clinical stage of product development for CE and FDA approval.Detailed understanding of ISO 13485.Managerial experience is preferred.Strategic thinking and leadership skills.Excellent English language is a must.Ability to travel to Italy.

  • Privacy and Protection

    1 week ago

    Mendip, United Kingdom Reed- UNLIMITED Full time

    Experience working within information security and privacy and broader risk management. Experience of assessing key documents such as frameworks, policies and procedures.Understanding and working knowledge of Privacy, Data Protection and Information Security principles and protocols.Flexible and responsive with a proactive approach to problem solving.Able...

  • L&D Project Manager, London

    1 week ago

    Mendip, United Kingdom Publicis Groupe Full time

    L&D Project Manager101 Wood Lane, London, W12 7FWCompany DescriptionPublicis Groupe UK is a marketing and digital transformation business made up of 5,000 talented and versatile people with expertise in media, creative, influence, technology and data, working across 21 agencies.Publicis Groupe UK creative agencies include Saatchi & Saatchi, BBH, Digitas, Leo...

  • Credit Controller

    7 days ago

    Mendip, United Kingdom Reed- UNLIMITED Full time

    Thorn Baker have an exciting opportunity that you wouldn't want to miss out on... We’re growing our Credit Control team! We’ve nearly doubled in size as a business over the last 3 years and as we’ve grown the needs of our clients have become more involved - this has generated the need for a somewhat unique role to work with the team and our Credit...

  • Junior Data Solutions Manager, London

    1 week ago

    Mendip, United Kingdom Publicis Groupe Full time

    Junior Data Solutions ManagerWood Lane, London, W12Company DescriptionPublicis Media is the world's second largest media agency network and part of the French communications group Publicis Groupe. As a global holding company, Publicis Media lives through its global agency brands Zenith, Starcom and Spark, which manage and continuously develop customer...

  • Data Solutions Manager, London

    1 week ago

    Mendip, United Kingdom Publicis Groupe Full time

    Data Solutions Manager101 Wood Lane, London, W12 7FWCompany DescriptionPublicis Media is the world's second largest media agency network and part of the French communications group Publicis Groupe. As a global holding company, Publicis Media lives through its global agency brands Zenith, Starcom and Spark, which manage and continuously develop customer...

  • Senior Global Investment

    1 week ago

    Mendip, United Kingdom Publicis Groupe Full time

    Senior Global Investment & Accountability Executive101 Wood Lane, London, W12 7FWCompany DescriptionPublicis Media is one of the world's largest media agency network and part of the French communications group Publicis Groupe. As a global holding company, Publicis Media lives through its global agency brands Zenith, Starcom and Spark, which manage and...