Regulatory Affairs Professional

Vor 3 Tagen


Zürich, Zürich, Schweiz elemed Vollzeit
Company Overview

Elemed is a well-established company in Zurich, Switzerland, designing and developing innovative Class III active-implantable medical devices. Our products are CE marked and have a significant impact on patients' lives.

Job Description

The Senior Regulatory Affairs Specialist will join our close-knit team to support the expansion of our QA/RA department. As a key member, you will work closely with top experts in their field, developing your skills and advancing your career.

  • Manage technical documentation on an international scale
  • Maintain the CE mark and PMA
  • Act as the point of contact with notified bodies and health authorities
  • Support the VP RA/QA and Director of RA/QA with maintenance activities for regulatory affairs
  • Lead design control meetings and activities, including creation and maintenance of technical documentation, DHFs, DMRs
  • Advise on development and remediation projects from a regulatory perspective
  • Support electrical safety and software-related activities
  • Evaluate processes and assess the impact on regulatory compliance
Required Skills and Qualifications
  • At least 3 years of experience in Regulatory Affairs within the medical device industry
  • A deep understanding of IEC 60601-1
  • CE marking experience is essential
  • Excellent communication skills in English
Benefits

We offer a dynamic and fast-paced work environment, opportunities for professional growth, and a chance to be part of a team that changes lives.

Others

If you're interested in exploring this opportunity further, please consider sending your CV to initiate a confidential career discussion.



  • Zürich, Zürich, Schweiz Real Staffing Vollzeit

    Job DescriptionWe are seeking a highly experienced Regulatory Affairs Professional to join our team. As a key member of our regulatory team, you will be responsible for leading the development and implementation of global market access strategies for our clients.Key Responsibilities:Develop and execute comprehensive market access plans to ensure timely...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    At Takeda, we are committed to fostering a culture of excellence and collaboration. As a Clinical Trial Regulatory Lead, you will be responsible for developing operational implementation plans for clinical trial applications (CTAs) in the EUCAN and GEM regions.This role requires strong regulatory experience, including knowledge of CTA regulations and...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    We're looking for a professional or recent graduate to join our Private Wealth Management (PWM) Compliance team in Zurich. As a Regulatory Affairs Analyst, you'll provide compliance advisory and surveillance to our PWM business.About the RoleYou'll be responsible for working closely with the PWM Swiss, London and European Compliance teams to deliver...


  • Zürich, Zürich, Schweiz La Prairie Group AG Vollzeit

    Responsibilities:We are seeking a dedicated Regulatory Affairs Specialist to join our team at the La Prairie Group AG. As a key member of our regulatory affairs team, you will be responsible for ensuring that all products comply with relevant regulations and industry standards.You will work closely with cross-functional teams to review and approve new...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    TN Switzerland, the global leader in professional resourcing and project-based workforce solutions, is seeking a seasoned Regulatory Affairs Strategist with expertise in Marketed Products Development, Growth and Emerging Markets (GEM).About the Role:We are looking for an experienced candidate to lead our regulatory efforts in GEM, collaborating with...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    As a Regulatory Affairs Consultant, you will play a crucial role in ensuring our client's compliance with regulatory requirements.About the Role:You will assist in reviewing CRS and FATCA entity classifications and reportable persons within the control framework.Collaborate with the management team to ensure all registrations are up-to-date.Develop and...


  • Zürich, Zürich, Schweiz elemed Vollzeit

    Job OverviewThis is an exciting opportunity to join a close-knit team with a shared vision, surrounded by senior experts in their field. You will work on developing your skills and furthering your career while supporting the continuation of the regulatory strategy for a life-changing medical device.


  • Zürich, Zürich, Schweiz SciPro Vollzeit

    Company OverviewScipro is a specialist life sciences consultancy based in Switzerland, providing expertise in regulatory affairs and quality management for medical software products.


  • Zürich, Zürich, Schweiz Ecofact Ag Vollzeit

    Role DescriptionWe're looking for a Pharmaceutical Legal Specialist to join our ESG Regulatory team.The ideal candidate will have a good understanding of sustainability/ESG issues relevant to the pharmaceutical sector and be able to contribute to ECOFACT's research on these topics.Responsibilities:Contribute to ECOFACT's research on sustainability/ESG topics...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    We are searching for an experienced Clinical Trials Lawyer to join our team at TN Switzerland.About the Job:This role involves providing expert advice and counsel on a range of legal matters related to clinical trials law. The successful candidate will have excellent communication and negotiation skills, as well as a strong understanding of regulatory...


  • Zürich, Zürich, Schweiz Stettler Consulting AG Vollzeit

    Wir suchen eine flexible und belastbare Persönlichkeit als Abteilungsleiter/in für die regulatorische Betreuung von Human- und Veterinärpräparaten. Als Teil unseres Teams haben Sie die Möglichkeit, Ihre Fähigkeiten und Erfahrungen zu nutzen.AufgabenFührung, Coaching und Weiterentwicklung des Regulatory- und Medical-TeamsAufteilung der...


  • Zürich, Zürich, Schweiz elemed Vollzeit

    About UsElemed is a commercial-stage company based in Zurich, Switzerland, focused on developing and producing innovative medical devices. Our products have already achieved CE certification and continue to make a positive impact on patients' lives.Role SummaryThis Senior Regulatory Affairs Specialist position requires an expert in regulatory affairs for...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    At TN Switzerland, we value diversity and promote an inclusive environment for our employees.We are a dynamic organization seeking talented individuals who share our commitment to excellence.The EUCAN (Europe & Canada) Regulatory Therapeutic Area Team Lead for Oncology will oversee all regulatory activities related to oncology products in the region.This...


  • Zürich, Zürich, Schweiz elemed Vollzeit

    Position OverviewElemed is seeking a highly experienced Senior Regulatory Affairs Specialist to drive the expansion of our QA/RA team. The ideal candidate will possess strong leadership skills, regulatory expertise, and the ability to work in a dynamic environment.Key ResponsibilitiesOversee international technical documentation managementMaintain regulatory...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    We are looking for a highly motivated and experienced Senior Regulatory Professional to join our team at TN Switzerland.About the JobThe successful candidate will be responsible for leading the development and implementation of effective compliance programs within the organization.Key responsibilities include assessing and updating internal policies to...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    At TN Switzerland, we are seeking a highly skilled Manager Regulatory Compliance to join our team in Zurich. This role will focus on ensuring compliance with regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets.About the Job:The ideal candidate will have significant experience within...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    Do you have a strong background in regulatory affairs and a passion for strategy development? If so, we invite you to apply for our Regulatory Manager Market Access role.About the Job:This key position involves collaborating with cross-functional teams to develop and implement regulatory strategies for Marketed Products in GEM, ensuring compliance with...


  • Zürich, Zürich, Schweiz Real Staffing Vollzeit

    Senior Regulatory Affairs RoleWe are looking for a highly experienced Pharmaceutical Regulatory Lead to join our team. As a key member of our regulatory team, you will be responsible for leading the development and implementation of regulatory strategies that meet business objectives.Key Responsibilities:Develop and execute comprehensive regulatory...


  • Zürich, Zürich, Schweiz elemed Vollzeit

    About the RoleThis Senior Regulatory Affairs Specialist position involves working on various elements within Regulatory on an international scale. Responsibilities include management of technical documentation, maintaining CE mark and PMA, and acting as the point of contact with notified bodies and health authorities.


  • Zürich, Zürich, Schweiz Givaudan Vollzeit

    Givaudan is a leading global company that creates flavours and fragrances for the food, beverage and personal care industries. We are committed to delivering high-quality products that meet our customers' needs.Job Summary:This role involves working within our Taste & Wellbeing Global Regulatory Advocacy & Science Department to develop and create global...