Regulatory Affairs Specialist for Medical Devices

hace 1 día


Barcelona, Barcelona, España Zimvie Us Corp Llc A tiempo completo
Job Description

We are ZimVie, a leading global life sciences company dedicated to restoring daily life for our patients through innovative medical solutions. Our mission is built on a legacy of trusted brands and products, supported by an inclusive culture that empowers our team members to bring their best selves to work every day.

About the Role

The Regulatory Affairs Senior Specialist EMEA will lead and prepare technical documentation, including biocompatibility, clinical, and post-market surveillance reports. This role will assist the Global Regulatory Affairs Manager with topics related to clinical affairs, regulatory compliance, and regulatory affairs.

Key Responsibilities
  • Prepare CERs for Technical Documentations
  • Maintain and prepare Technical Documentations according to EU MDR requirements
  • Review new regulatory requirements and implement them accordingly
  • Support QMS maintenance and alignment with ZimVie's QMS
  • Participate in External and Internal audits
Requirements

To be successful in this role, you will need:

  • University degree in a Science-related subject (e.g., Biology, Biotechnology, Pharmacy)
  • 5 years' experience in a similar position
  • SME in ISO 10993, ISO 14155, ISO 13485, EU MDR implementation, FDA 21 CFR 820, and submission of 510(k)
  • Fluent in English; other European languages are a plus
What We Offer

ZimVie offers a challenging position with good career prospects in an international medical device business, along with:

  • Competitive compensation package: $80,000 - $110,000 per annum, depending on experience
  • Permanent contract
  • Meal allowance
  • Partially remote work option available
  • Private life, health, and dental insurance
  • Learning & development program

This is an exciting opportunity to join our diverse and collaborative global team, embracing innovative curiosity, personal authenticity, accountability, and a growth mindset.



  • Barcelona, Barcelona, España Com si fos ahir A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Com si fos ahir. The successful candidate will be responsible for ensuring regulatory compliance and ensuring that our medical devices meet the highest standards.About the RoleThe Regulatory Affairs Specialist will be responsible for providing expert knowledge and...


  • Barcelona, Barcelona, España Ablecloset A tiempo completo

    **Job Summary**Ablecloset is seeking a highly skilled Regulatory Affairs Specialist to join our Corporate Regulatory Affairs Team. The ideal candidate will have a minimum of 5 years of experience in Pre-Market Regulatory Affairs within the Medical Device industry, with active medical devices (energy devices).**Key Responsibilities**Ensure regulatory...


  • Barcelona, Barcelona, España Ablecloset A tiempo completo

    **Job Title:** Regulatory Affairs Expert for Medical Devices**About the Role:We are seeking a highly skilled Regulatory Affairs Expert to join our team in Esplugues del Llobregat, Barcelona.**Company Overview:Ablecloset is a leading company in the medical device industry, and we are committed to delivering innovative solutions that meet the highest...


  • Barcelona, Barcelona, España Sinclair EBD A tiempo completo

    Regulatory Affairs Specialist Job DescriptionSinclair EBD is seeking a skilled Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices. As a key member of our team, you will ensure compliance with international regulatory authorities and support market entry for EBDs worldwide.About...


  • Barcelona, Barcelona, España The Zonal Group A tiempo completo

    About The Zonal Group: As a global medical aesthetics organisation, we deliver an extensive product range with an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets. Our products are sold in 55 countries worldwide.Job Description: We are seeking a Regulatory Affairs Specialist to manage the...


  • Barcelona, Barcelona, España Divurgent A tiempo completo

    Join Sinclair as a Regulatory Affairs SpecialistSinclair, a global medical aesthetics organisation, is seeking an experienced Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBDs). This role will involve ensuring compliance with international regulatory authorities and supporting...


  • Barcelona, Barcelona, España The Zonal Group A tiempo completo

    **Company Overview**Sinclair is a global medical aesthetics organisation founded in 1971, delivering an extensive product range worldwide. With an in-house commercial infrastructure and a network of distributors, our products are sold in 55 countries.**Job Summary**We are seeking a highly skilled Regulatory Affairs Specialist to manage global product...


  • Barcelona, Barcelona, España The Zonal Group A tiempo completo

    About the Job: We are looking for a Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBD). In this role, you will ensure compliance with international regulatory authorities and support market entry for EBDs worldwide.Key Responsibilities:Manage complex projects and deliverables...


  • Barcelona, Barcelona, España The Zonal Group A tiempo completo

    About The Zonal GroupWe are a global medical aesthetics organization that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.Job OverviewThe Regulatory Affairs Specialist will be responsible for...


  • Barcelona, Barcelona, España Com si fos ahir A tiempo completo

    Job Details: We are seeking a highly skilled Regulatory Affairs Engineer to join our Corporate Regulatory Affairs Team in Esplugues del Llobregat, Barcelona. The successful candidate will play a crucial role in ensuring regulatory requirements are met for new product development and design changes to established legacy devices.The Role: As a Regulatory...


  • Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completo

    At Dsm Nutritional Products, we are looking for a Regulatory Affairs Specialist to join our team in Barcelona. In this role, you will be responsible for providing technical support to the Perfumery and Beauty Documentation team.Key responsibilities include preparing standard documents and basic questionnaires for worldwide customers, using our internal...


  • Barcelona, Barcelona, España Werfen A tiempo completo

    The Regulatory Affairs department at Werfen is seeking a highly skilled Quality and Regulatory Affairs specialist to join our team in Barcelona, Spain.As a Quality and Regulatory Affairs specialist, you will be responsible for supporting the execution of pre and post-market regulatory affairs departmental functions. This includes assisting in the preparation...


  • Barcelona, Barcelona, España Ramboll Group AS A tiempo completo

    Ramboll Group A/S is a leading consulting engineering company, and we're looking for an experienced Regulatory Affairs Specialist to join our Health Sciences service line in Barcelona, Spain. Estimated Salary: 80,000 - 110,000 EUR per yearAbout the RoleAs a Regulatory Affairs Specialist for Biocides, you will be responsible for assisting with projects...


  • Barcelona, Barcelona, España FARMAPROJECTS SAU A tiempo completo

    Farmaprojects SAU is a B2B Pharmaceutical Laboratory company offering a broad portfolio of generic pharmaceutical products and value-added medicines. We are looking for a Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department.Key responsibilities include:Developing assessments and strategic regulatory plans for strategic product...


  • Barcelona, Barcelona, España Amgen A tiempo completo

    Senior Associate Regulatory AffairsAbout the Role:In this role, you will support marketed products and investigational in vitro diagnostic medical devices to be used in combined trials under the supervision of an experienced Local Regulatory Lead. Key responsibilities include:• Aligning local regulatory requirements with Amgen's corporate standards.•...


  • Barcelona, Barcelona, España Solutiaghs A tiempo completo

    Solutia Life Sciences, a leading recruitment division, specializes in technical and middle management profiles in the pharmaceutical, biotech, and medical device sectors.We are seeking an experienced professional to oversee product compliance, including documentation and processes, to meet regulatory requirements and interact with institutions for our...


  • Barcelona, Barcelona, España European Telemedicine Clinic A tiempo completo

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at European Telemedicine Clinic in Barcelona. This is a full-time position that requires a Bachelor's degree or master's degree in technical/process engineering/QA/ Medical Device discipline, with significant related professional experience within the laboratory environment.The...


  • Barcelona, Barcelona, España FARMAPROJECTS SAU A tiempo completo

    About FARMAPROJECTS SAUFARMAPROJECTS SAU is a B2B Pharmaceutical Laboratory company offering a broad Portfolio of Generic Pharmaceutical Products and Value Added Medicines.We are looking for a new Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department and contribute to the business.About the RoleAs a Regulatory Affairs Senior...


  • Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completo

    Overviewdsm-firmenich, a leading company in the field of nutritional products, is seeking a Regulatory Affairs Specialist for Raw Materials to join its team. This role offers a unique opportunity to work with cutting-edge technology and contribute to shaping the future of compliance.


  • Barcelona, Barcelona, España DSM A tiempo completo

    Regulatory Affairs Documentation TeamDSM is seeking a skilled Regulatory Affairs Documentation Specialist to join our team in the Regulatory Affairs Documentation Department. As a key member of our team, you will be responsible for collecting and maintaining regulatory information concerning our products for dsm-firmenich customers worldwide.Key...