Medical Device Regulatory Specialist

vor 3 Wochen


Neuenburg, Neuenburg, Schweiz Sound United Vollzeit

Sound United is a dynamic and innovative company seeking an experienced Medical Device Regulatory Specialist to join our team. The ideal candidate will have expertise in medical device regulations, requirements, and standards, as well as excellent communication and organizational skills.

About the Role

We are looking for a highly motivated and detail-oriented individual to support our regulatory affairs team with day-to-day projects and initiatives. This role involves preparing and coordinating country submissions for medical devices in EMEA, maintaining regulatory certificates and licenses, and supporting distributor registration activities.

Responsibilities
  1. Regulatory Affairs Coordination: Assist in registrations to the MDD/MDR in the EU and national requirements, achieving company objectives and timelines in the EMEA region.
  2. Certificate Management: Maintain schedule for renewal of regulatory certificates and licenses, and process and maintain requests to support distributor medical device registration activities.
  3. Documentation and Record-Keeping: Update technical documentation taking into account regulatory requirements, maintain regulatory affairs files, and list and distribute information as required.
  4. Meetings and Project Support: Support scheduling and arrangements for regulatory meetings, and perform other duties or special projects as assigned.
Requirements
  • Regulatory Knowledge: Proficient in global medical device regulations, requirements, and standards, such as ISO 13485, European Medical Device Directive, and Regulation (EU) 2017/745.
  • Communication Skills: Excellent verbal and written communication skills, with ability to work effectively in a matrix environment with non-local and local leadership.
  • Education: Bachelor's degree, or equivalent combination of education and experience, in science, engineering, medical/healthcare, or regulatory science.
  • Experience: 2-5 years of related work experience, preferably within a medical device company, working as part of an international organization.
Benefits

We offer a competitive salary range of $80,000 - $110,000 per year, depending on experience, plus benefits and opportunities for professional growth and development.



  • Neuenburg, Neuenburg, Schweiz Masimo Vollzeit

    Job Title: Medical Device Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Medical Device Regulatory Affairs Specialist to support registrations in the EMEA region. The ideal candidate will have fluency in English and knowledge of global medical device regulations.Prepare country submissions and maintain regulatory certificatesSupport...


  • Neuenburg, Neuenburg, Schweiz Sound United Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sound United. This is a key position that will play a crucial role in ensuring compliance with regulatory requirements for medical devices in the EMEA region.


  • Neuenburg, Neuenburg, Schweiz Sound United Vollzeit

    Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sound United. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the EMEA region.Key Responsibilities:Prepare and coordinate country submissions for medical devices in...


  • Neuenburg, Neuenburg, Schweiz Sound United Vollzeit

    Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sound United. The successful candidate will be responsible for ensuring compliance with EU regulations and standards, including the Medical Device Regulation (MDR) and the European Medical Device Directive (MDD).Key Responsibilities:Prepare and coordinate country...


  • Neuenburg, Neuenburg, Schweiz Aktiia Vollzeit

    About AktiiaWe are an early-stage, venture-backed start-up with a pioneering technology in continuous blood pressure monitoring. Our solution has been validated through extensive clinical trials and received a CE Mark as a Class IIa medical device, providing us with commercial access to 43 countries worldwide.


  • Neuenburg, Neuenburg, Schweiz GLOBAL JOB SERVICES COMPANY LIMITED Vollzeit

    Job SummaryWe are seeking a highly skilled Medical Specialist Pathologist to join our team at GLOBAL JOB SERVICES COMPANY LIMITED. This role involves performing diagnostic activities, including intraoperative consultations and on-call duties.Key Responsibilities:Perform daily macroscopic and microscopic examination of biopsies and surgical...


  • Neuenburg, Neuenburg, Schweiz Aktiia Vollzeit

    Company OverviewAktiia is a pioneering start-up that has developed the world's first continuous blood pressure monitor. Our technology is based on 15 years of research by our founders at the prestigious Swiss Center for Electronics and Microtechnology (CSEM). Our solution has been validated through extensive clinical trials and received a CE Mark as a Class...


  • Neuenburg, Neuenburg, Schweiz AQC Vollzeit

    Job DescriptionAQC is seeking a highly skilled Senior Quality Assurance Specialist to join our team. The ideal candidate will have extensive experience in chemical compliance and quality management, as well as ESG and Regulatory Affairs.About the RoleThe Senior Quality Assurance Specialist will be responsible for ensuring the smooth running of AQC's...


  • Neuenburg, Neuenburg, Schweiz Michael Page Vollzeit

    Michael Page is seeking a highly skilled Senior Verification IC Design Engineer to join our team. As a key member of our engineering team, you will be responsible for designing and verifying low-power devices that meet industry needs.About the RoleThis is an exciting opportunity to work on cutting-edge projects and contribute to the development of innovative...


  • Neuenburg, Neuenburg, Schweiz Michael Page Switzerland Vollzeit

    The role of Senior Low-Power IC Design Verification Specialist at Michael Page Switzerland is a highly technical position that requires expertise in mixed-signal semiconductor design and verification.As a key member of the team, you will be responsible for architecting and verifying connected, low-power devices, translating customer needs into technical...


  • Neuenburg, Neuenburg, Schweiz Bulgari Vollzeit

    Job OverviewAt Bulgari, we are seeking a Perfume Sustainability Specialist to join our Environment and Regulatory Affairs team. This role will play a crucial part in promoting sustainable development within our organization.About the RoleWe are looking for a results-driven professional with a proven track record in sustainability to lead our environmental...


  • Neuenburg, Neuenburg, Schweiz Ant-Tech Vollzeit

    Job SummaryAnt-Tech is seeking a highly skilled Pathology Specialist to join our team. This permanent position offers an attractive salary and comprehensive benefits package.The successful candidate will hold a federal medical diploma and an FMH specialization in pathology or equivalent qualification recognized by MEBEKO. They will possess solid and...


  • Neuenburg, Neuenburg, Schweiz Michael Page Switzerland Vollzeit

    System Architect Job DescriptionThis is a challenging role for an experienced System Architect Designer who specializes in connected, low-power MCU and DSP products.The successful candidate will develop specifications and system designs that balance functionality, power efficiency, and cost while ensuring seamless integration across different parts of the...


  • Neuenburg, Neuenburg, Schweiz Takeda Vollzeit

    Job Summary: We are seeking a highly skilled Quality Assurance Expert to join our team at Takeda Neuchatel. As a Quality Assurance Expert, you will be responsible for ensuring the quality of our Bulk Drug Substances manufacturing activities.Key Responsibilities:• Provide support and guidance to production team units in their routine activities directly on...


  • Neuenburg, Neuenburg, Schweiz Sound United Vollzeit

    About the Role:Sound United is seeking a highly skilled Senior Financial Analyst to join our team as a Revenue Accounting Specialist. This role will play a critical part in ensuring the accuracy and integrity of our financial reporting.Job Summary:The Senior Financial Analyst, Revenue Accounting Specialist will be responsible for reviewing, evaluating, and...


  • Neuenburg, Neuenburg, Schweiz Michael Page Vollzeit

    About the RoleWe are seeking a highly skilled Senior IC Design Verification Engineer to join our team at Michael Page. As a key member of our verification team, you will be responsible for designing and verifying low-power devices that meet customer needs.Key ResponsibilitiesArchitect and verify connected, low-power devices, translating customer needs into...


  • Neuenburg, Neuenburg, Schweiz Semtech Vollzeit

    Job Overview:Semtech is seeking a highly skilled Applications Engineer to join our team. As a key member of our team, you will be responsible for leading new product validation, generating technical documents, and developing evaluation boards.Responsibilities:Validate new products to ensure compliance with specifications and expected functional...


  • Neuenburg, Neuenburg, Schweiz Takeda Vollzeit

    At Takeda, we are committed to delivering novel specialty pharmaceuticals and best-in-class patient support programs that transform patient care. As a Quality Control Supervisor, you will play a pivotal role in ensuring the efficiency and accuracy of our laboratory operations.About the Role:This is an exciting opportunity for a motivated individual with...


  • Neuenburg, Neuenburg, Schweiz Michael Page Vollzeit

    Job DescriptionWe are seeking a Senior IC Verification Engineer to join our team at Michael Page.ResponsibilitiesDesign and verify low-power devices, ensuring they meet customer needs and industry standards.Collaborate with cross-functional teams to maximize IP reuse and drive innovation in semiconductor design.Develop and implement formal verification...


  • Neuenburg, Neuenburg, Schweiz Takeda Vollzeit

    About the Role:The Vision Engineer Fill Finishing is responsible for ensuring the quality and integrity of filled products through automated inspection systems. This role requires a strong background in software development, image processing, and machine learning.Key Responsibilities:Design and implement automated vision inspection systems for fill finishing...