Regulatory Specialist
vor 2 Wochen
At ONWARD we're looking for a Regulatory Specialist to join our team.
About the jobThe Regulatory specialist collaborates closely with the Development, Quality and Clinical teams for the preparation and submission of Regulatory Technical documentation (with focus on EU and US authorities).
Responsibilities
- Hands-on support with the Development, Quality and Clinical teams to prepare technical documentation in compliance with country specific regulations (EU and US).
- Maintain and update technical files to support submissions for market approval and clinical trials (EU and FDA).
- Maintain applicable standards list and traceability between technical documents and applicable standards.
- Manage Packaging and Labeling requirements.
- Perform routine regulatory monitoring, and coordinate with Subject matter experts the impact analysis of new/updated standards.
- Perform regulatory impact analysis on design change requests.
- Masters’ degree in Biomedical Engineering or equivalent, with a specialization in Regulatory.
- 3-5 years of experience in Medical Device regulatory. Experience with Active Implantable Devices is a plus.
- Hands-on experience with the use of quality management system (ISO 13485), Risk management (ISO 14791), Biocompatibility ISO 10993 series and other horizontal standards such as ISO 62304, IEC 60601, ISO 62366, ISO 15223-1, ISO 14155.
- Understanding of Regulatory processes in Medical devices - Medical Device Regulation and FDA pathway.
- Experience with EU MDR technical documentation preparation and FDA submission packages.
- Experience with Documentary requirements for clinical studies with medical devices.
- A high energy, fast-learner, self-motivated, pro-active personality able to work in a diverse team within a startup company; willing to help colleagues.
- Fluent in English and French.
- Represents the ONWARD CODE (values): Empowered, Committed, Pragmatic, Innovative, Open, Trusting, Collaborative and Passionate.
Do you want to join our team as our new Regulatory Specialist? Then we'd love to hear about you
#J-18808-Ljbffr-
Regulatory Specialist
vor 3 Wochen
Lausanne, Schweiz ONWARD Medical VollzeitAt ONWARD we're looking for a Regulatory Specialist to join our team. Full-time · Lausanne About the job The Regulatory specialist collaborates closely with the Development, Quality and Clinical teams for the preparation and submission of Regulatory Technical documentation (with focus on EU and US authorities). Responsibilities Hands-on support with the...
-
Regulatory Compliance Specialist
Vor 5 Tagen
Lausanne, Waadt, Schweiz Michael Page VollzeitJob OverviewA talented Regulatory Compliance Specialist is needed to join our team at Michael Page. This role is perfect for an individual with a strong background in compliance and a passion for ensuring that our banking activities are carried out in accordance with the latest regulations.
-
Regulatory Compliance Specialist
Vor 7 Tagen
Lausanne, Waadt, Schweiz Michael Page VollzeitAbout the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Michael Page.Job DescriptionKey Responsibilities:Ensure compliance with regulatory requirements and industry standards.Manage bank relationships, including mandate updates and due diligence processes.Conduct research on regulatory changes and ensure adherence...
-
Regulatory and Scientific Affairs Senior Specialist
vor 2 Monaten
Lausanne, Schweiz Nestlé VollzeitPosition SnapshotLocation: Nestlé Research, Lausanne, Switzerland Institute: Scientific & Technical Operations Unit Company: Société des Produits Nestlé S.A.Act. Rate: Full-Time Act. Rate 100%Type of contract: Permanent contract Important Information: After submitting your application, you will be automatically invited to record a video introduction...
-
Accounting Specialist
vor 3 Wochen
Lausanne, Waadt, Schweiz CSD INGÉNIEURS SA VollzeitWe are seeking an experienced Accounting Specialist to join our team. The successful candidate will be responsible for preparing financial statements, managing budgets, and ensuring compliance with regulatory requirements. Key responsibilities include:Preparing financial statements and reportsManaging and analyzing financial dataDeveloping and implementing...
-
Clinical Research Officer
vor 1 Monat
Lausanne, Waadt, Schweiz Aixial Group VollzeitClinical Research Officer - GCP SpecialistJoin Aixial Group, a leading CRO in Life Science, and take on the role of Clinical Research Officer - GCP Specialist. Our team is dedicated to providing technical support on clinical projects from phases I to IV and post-market.We are a dynamic and growing company, with a strong presence in Switzerland, France,...
-
Regulatory Compliance Specialist
vor 2 Wochen
Lausanne, Waadt, Schweiz Capgemini VollzeitAt Capgemini Engineering Switzerland, we value excellence, diligence, responsibility, dynamism, and innovation. Our diverse workplace offers a unique opportunity for professional and personal growth. We seek a skilled CQV Engineer to join our team.Key Responsibilities:Develop and execute validation protocols to ensure compliance with regulatory...
-
CQV Specialist
vor 4 Wochen
Lausanne, Waadt, Schweiz Capgemini VollzeitAbout the RoleCapgemini Engineering Switzerland is seeking an experienced CQV Specialist to join our team. As a CQV Specialist, you will be responsible for ensuring processes, instruments, and facilities are compliant with regulatory standards. Your expertise will be essential in developing and executing validation protocols, commissioning and qualifying...
-
Senior Oncology Clinical Document Specialist
vor 5 Stunden
Lausanne, Waadt, Schweiz Debiopharm VollzeitJob DescriptionWe are seeking a highly skilled Senior Oncology Clinical Document Specialist to join our team at Debiopharm, a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases. The ideal candidate will have a strong background in clinical document development, regulatory compliance, and collaboration...
-
Accounting Specialist
vor 3 Wochen
Lausanne, Waadt, Schweiz Fondation de La Côte VollzeitJob Description: We are seeking a highly skilled and detail-oriented Accounting Specialist to join our team. The ideal candidate will have excellent analytical and communication skills, with a strong understanding of financial regulations and compliance.Key Responsibilities:Prepare and review financial statements, ensuring accuracy and compliance with...
-
Senior Quality Assurance Specialist
vor 4 Wochen
Lausanne, Waadt, Schweiz Randstad (Schweiz) AG VollzeitJob Description:Our client, a leading biopharmaceutical company in Vaud canton, is seeking a Senior Quality Assurance Specialist for Computerized Systems Validation (CSV) to join their team.Responsibilities:As a Senior Quality Assurance Specialist for CSV, you will be responsible for managing quality oversight for computerized systems validation and data...
-
Senior Compliance Specialist
vor 1 Woche
Lausanne, Schweiz MeetFrank VollzeitBe part of SwissBorg's fast-growing community with over $1.5 billion assets and a vibrant user base.SwissBorg is innovating wealth management with blockchain, offering the best liquidity and rates, and empowering users through their Wealth App.A Swiss-headquartered company that offers a unique opportunity within the fintech and blockchain space, appealing to...
-
Senior Quality Assurance
vor 4 Monaten
Lausanne, Schweiz Randstad (Schweiz) AG VollzeitJobdescriptionFor our client based in Vaud canton and specialized in biopharmaceutical area, we're looking for a Senior Quality Assurance - CSV specialist ResponsabilityManage Quality oversight for computerized systems validation and the data integrity program & support QA activities for system introduction/upgrades, ensuring compliance with quality...
-
Innovative Product Development Specialist
Vor 2 Tagen
Lausanne, Waadt, Schweiz Michael Page Switzerland VollzeitAt Michael Page Switzerland, we are seeking an Innovative Product Development Specialist to join our client's Technical team.You will be responsible for designing, developing, and optimising high-end medical devices products. This role involves supporting the industrialisation process and working closely with external partners to bring innovative solutions...
-
Senior Specialist Allergy
Vor 4 Tagen
Lausanne, Schweiz Nestlé SA VollzeitImportant Information: After submitting your application, you will be automatically invited to record a video introduction guided by specific questions. This video introduction should take no longer than 10 minutes. Once this step is completed, we would be pleased to consider your application and assess your profile accordingly. Kindly be informed that we...
-
Quality Assurance Specialist
vor 2 Wochen
Lausanne, Waadt, Schweiz Michael Page Switzerland VollzeitRole OverviewIn this key position, you will lead the quality system of a dynamic organisation from design to manufacturing process.You will be responsible for managing risk management activities and ensuring compliance with regulatory standards such as ISO 13485.
-
Data Scientist for Clinical Research
vor 2 Wochen
Lausanne, Waadt, Schweiz Aixial Group VollzeitClinical Research Professional with Specialized ExpertiseAixial Group, a leading CRO in Life Science, seeks a skilled professional to support clinical operations and regulatory affairs.Our team collaborates with laboratories to provide technical support on clinical projects from phases I to IV and post-market.As a specialist in GCP, you will contribute to...
-
Senior Specialist Allergy
vor 5 Stunden
Lausanne, Schweiz Nestlé SA VollzeitImportant Information: After submitting your application, you will be automatically invited to record a video introduction guided by specific questions. This video introduction should take no longer than 10 minutes. Once this step is completed, we would be pleased to consider your application and assess your profile accordingly. Kindly be informed that we...
-
Senior Clinical Operations Specialist
vor 3 Wochen
Lausanne, Waadt, Schweiz Aixial Group VollzeitAixial Group is a CRO (Clinical Research Organization) specialized in Life Science, providing technical support on clinical projects from phases I to IV and post market. Our team works with laboratories to deliver high-quality services.We are part of the Alten family and have been expanding our activities in Switzerland, France, Belgium, Czech Republic,...
-
Lausanne, Waadt, Schweiz Agap2 VollzeitJob DescriptionWe are seeking an experienced Industrial Maintenance Specialist to join our team in Lausanne. As a key member of our maintenance team, you will be responsible for improving the reliability of equipment and utilities on pharmaceutical and biotech production sites.Main Responsibilities:Manage and supervise preventive and corrective maintenance...