Ra & Compliance Manager

hace 3 meses


Mendaro Guipúzcoa provincia, España Straumann Group A tiempo completo

ABOUT STRAUMANN

Headquartered in Basel, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Having pioneered many of the most influential technologies and tech-niques in our field, we have a tradition of doing more to advance dental regeneration, restora-tion and replacement, as well as patient care. Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape our future and create impact. Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.

ABOUT THE ROLE
- Reporting directly to the Quality Manager, the main tasks assigned for the position are:

- Working in the Quality Assurance - Regulatory Affairs Department, helping to maintain and improve the integrated and MDR compliant QMS.
- Implement new Regulations/Standards in the QMS.
- Maintain up to date regulatory compliance for each geographical area.
- Involve in all processes, review, prepare and maintain related procedures.
- Prepare technical documentation following EU regulatory requirements.
- Implement harmonised standards.
- Provide development and support to achieve departmental objectives.
- Be proactive in identifying opportunities for improvement in the QA/RA department.
- Collaborate in planning and problem solving procedures to ensure continuous improvement in the QA/RA department.
- Internal audits: perform product and process audits to ensure compliance with standards.
- Work cooperatively with subcontractors on new technical and customer requirements, including audits and monitoring of their QMS procedures.
- Collaborate with other departments to ensure that QMS requirements are deployed in accordance with the PLM.
- Perform Post Market Surveillance (PMS), Post Market Clinical Follow-up (PMCF), Clinical Evaluation of medical devices in accordance with the MDR and clinical database management.

Desirable competences
- Knowledge of MDR and ISO 13485
- Initiative
- Interest in innovation
- Ability to teach and transfer knowledge
- Ability to become technically proficient in the assigned area
- Ability to obtain and analyse information
- Creative thinking
- Ability to synthesise
- Languages: English level B1 or higher



  • Mendaro, España Straumann Group A tiempo completo

    About Straumann Headquartered in Basel, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Having pioneered many of the most influential technologies and techniques in our field, we have a tradition of doing more to advance dental regeneration, restoration and replacement, as well as patient care. Straumann...


  • Benifaió, Valencia provincia, España Roquette A tiempo completo

    Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and...

  • Internal Control

    hace 7 meses


    Oliva, Valencia provincia, España Refresco Deutschland GmbH A tiempo completo

    Internal Control & Compliance Manager Resportando al Finance & IT Director, el/la Internal Control & Compliance Manager se encargará de Supervisar los sistemas de control interno y compliance de Refresco Iberia para garantizar el cumplimiento con los principios básicos, leyes externas y requisitos legales, asumiendo la coordinación de las auditorías...

  • Compliance Manager

    hace 4 meses


    Tres Cantos, Madrid provincia, España Sener A tiempo completo

    En Sener deseamos incorporar en nuestro equipo a un/a Compliance Manager en nuestro centro de trabajo de Tres Cantos. Somos un grupo privado de ingeniería y tecnología compuesto por más de 3.500 profesionales y expertos en más de 100 disciplinas técnicas en oficinas en cinco continentes. Integramos nuestros conocimientos para encontrar la mejor...


  • Mendaro, España Createch A tiempo completo

    **#ChangeMakers** **Ready to make an impact?** We develop, manufacture and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to drive...


  • Mendaro, España Createch A tiempo completo

    **About Createch** Createch Medical is a dental engineering company, part of Straumann Group, with a wide range of structure solutions for prostheses. We manufacture high-resistance, personalised structures for every patient using materials certified by UNE-EN ISO regulations. Our designs include simulations using finite element analysis (FEA) calculations...

  • Compliance Manager

    hace 2 días


    Mallorca, Illes Balears provincia, España Hotelbeds A tiempo completo

    Hotelbeds is the world´s leading bedbank. The company’s proprietary technology helps providers of travel services distribute their offering to travel sellers globally via an easy-to-use, advanced technology platform that increases reach, revenue and yield for both the provider and the seller. Operating under the Hotelbeds brand in the wholesale channel...

  • Compliance Manager

    hace 2 semanas


    Mallorca, Illes Balears provincia, España Hotelbeds A tiempo completo

    Hotelbeds is the world’s leading technology partner, connecting and empowering the world of travel. We’re game-changers, disruptors, the people who bring together local and global brands in accommodation, transport, activities and payments through our network of 300,000 hotels worldwide, 60,000 hard to reach high value clients such as tour operators,...


  • Marbella, Málaga provincia, España AnyTech365 A tiempo completo

    **AnyTech365** is the leading IoT (Internet of Things) security solutions company in Europe. We offer protection services, help and support from the best professionals in our industry for all Internet-connected devices. Founded just 7 years ago, **AnyTech365** has grown exponentially from 70 to over 400 employees thanks to a policy focused on developing our...


  • Barberà del Vallès, Barcelona provincia, España Berry Global, inc A tiempo completo

    Overview: The Global Trade Compliance Manager will be responsible for assisting in the development, deployment and continuous improvement of trade and customs practices across the EAME Region as informed by the Director of Global Trade Compliance within Berry’s Legal Department. This position will help to ensure compliance with internal policies and...


  • Arganda del Rey, Madrid provincia, España Tetra Pak A tiempo completo

    At Tetra Pak we commit to making food safe and available, everywhere; and we protect what's good - protecting food, protecting people, and protecting the planet. By doing so we touch millions of people's lives every day. And we need people like you to make it happen_ **VAT Compliance Controller** Support Tax Ops and the Indirect Tax & Technology center of...


  • Súria, Barcelona provincia, España ICL Group A tiempo completo

    We are looking for an Accounting, Tax & Compliance Manager located in Súria (Barcelona). Supervises the daily activities in the accounting department, analyses, records, tracks, and audits financial information for all companies under ICL Iberia. Responsible for tax accuracy in daily operations for all companies, and tax reporting and compliance with...


  • Usurbil, Guipúzcoa provincia, España Danfoss A tiempo completo

    Requisition ID: 34173- Job Location(s): Usurbil, ESAs our new Quality and After Sales Manager, you will manage a team of 7 direct reports that will provide the knowledge for process&tools and guidance to protect customers brand and strengthen own organization quality culture. Helping everyone else to play their part in pursuing excellence by making sure,...


  • Cornellà de Llobregat, Barcelona provincia, España Alcon A tiempo completo

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...


  • 08174 Sant Cugat del Vallès, Barcelona provincia, España Hewlett Packard A tiempo completo

    **Take Back Expansion and Compliance Operations Manager** **Key responsibilities** - **Monitor Compliance/Regulatory Requirements in EMEA** - Monitor and ensure compliance with regulatory requirements for new countries and any changes in current countries. - Work closely with Sustainability teams and suppliers to uphold compliance standards. - Prepare and...


  • Torres, Jaén provincia, España Torres Strait Island Regional Council A tiempo completo

    **What we offer**: - ** Identified position**: - **Based at any TSIRC Division**: - **$63,752 - $66,976 per annum**: - ** Full time, Fixed Term until 30/06/2027**: - ** 6 weeks annual leave**: - ** Additional public holidays gazetted by TSIRC**: - ** Uniforms** **About us**: Torres Strait Regional Council (TSIRC) is the largest employer in the Torres...


  • León provincia, España IMAN GLOBAL CONSULTING A tiempo completo

    Desde **IMAN Global Consulting**, Consultoría de Selección de puestos medios y directivos/as, buscamos a un/a **Project Manager **para una importante empresa del sector automoción en Burgos. **Job details**: - Responsibility for the technical and commercial implementation of the assigned projects. - Responsibility for the successful implementation of...

  • Assistant Manager

    hace 2 semanas


    Navarra provincia, España Livensa Living A tiempo completo

    Livensa Living is currently the sales & marketing platform for Temprano Capital’s purpose-built student accommodation (“PBSA”) business. The objective is for Livensa Living to become a fully integrated operator of PBSA across Iberia. We are already we’re made up of really good people and we’re a business who will endeavour always to do the right...


  • Guadalajara, Guadalajara provincia, España Cummins A tiempo completo

    We are currently looking for a **Senior Contract Manager** to join the team. The role reports to the Risk Manager - ELECTROLYZER PROJECT MANAGEMENT DPT. Work model: Hybrid. **In this role, you will make an impact in the following ways**: - The primary focus of this position is to support the different company stakeholders in reviewing properly our...


  • Sant Cugat del Vallès, Barcelona provincia, España Gaming Laboratories International A tiempo completo

    While providing integrity to the casino and gambling industry for over 33 years, GLI has established an incomparable team of professionals. Join a global market leader in the gambling industry while gaining valuable experience to support a fast-paced, collaborative team. The Technical Compliance Engineer provides technical consulting services to regulators,...