Aktuelle Jobs im Zusammenhang mit Clinical-Regulatory Program Manager - Muri b Bern, Bern - Compremium AG
-
Regulatory Compliance Specialist
Vor 5 Tagen
Bern, Bern, Schweiz Pharmiweb VollzeitClinical trial supply management is a critical component of our pharmaceutical industry operations. We are seeking a skilled professional to manage and execute clinical trial supplies from setup through to closeout.This role involves coordinating the timely delivery, packaging, distribution, and destruction of clinical trial supplies, ensuring compliance...
-
Clinical Trials Manager
vor 14 Stunden
Bern, Bern, Schweiz beBee Careers VollzeitResponsibilitiesThe Clinical Trials Manager - Global Feasibility will be accountable for the development and implementation of feasibility strategies across clinical programs. This role requires strong leadership and communication skills, as well as the ability to analyze complex data and make informed decisions.Analyze program operational plans and options...
-
Bern, Bern, Schweiz Pharmiweb VollzeitWe are seeking an experienced and highly organized Clinical Trial Supply Manager to oversee the management and execution of clinical trial supplies from setup through to closeout. This role involves coordinating the timely delivery, packaging, distribution, and destruction of clinical trial supplies, ensuring compliance with regulatory standards and...
-
Clinical Trials Manager
vor 2 Wochen
Bern, Bern, Schweiz Universität Bern VollzeitAbout the PositionThe Clinical Trial Monitor is an essential member of the Department of Clinical Research, responsible for ensuring the quality and integrity of clinical trials. This role requires a strong understanding of regulatory requirements, excellent collaboration and communication skills, and the ability to work independently and collaboratively as...
-
Clinical Trial Supply Chain Manager
Vor 5 Tagen
Bern, Bern, Schweiz Pharmiweb VollzeitWe are seeking an experienced and highly organized professional to oversee the management and execution of clinical trial supplies from setup through to closeout. This role involves coordinating the timely delivery, packaging, distribution, and destruction of clinical trial supplies, ensuring compliance with regulatory standards and efficient processes...
-
Clinical Operations Manager
vor 2 Wochen
Bern, Bern, Schweiz Pharmiweb VollzeitHobson Prior is seeking a Clinical Operations Manager to oversee the planning and execution of clinical trials, ensuring all operational aspects are managed efficiently.As a key member of our team, you will work closely with various teams to ensure trial activities are completed on time and meet quality standards. Your ability to develop and manage...
-
Clinical Operations Manager
vor 2 Wochen
Bern, Bern, Schweiz Pharmiweb VollzeitAre you looking for a new role to shape the future of healthcare? Join our client as a Clinical Operations Manager and make your impact where it truly matters.Hobson Prior is seeking a Clinical Operations Manager to oversee the planning and execution of clinical trials, ensuring all operational aspects are managed efficiently. You will work closely with...
-
Head of Clinical Trials Unit
vor 2 Wochen
Bern, Bern, Schweiz Universität Bern VollzeitAbout the Role:The University of Bern seeks a highly motivated and experienced professional to fill the position of Head of Clinical Trials Unit. As a key member of our team, you will lead and contribute to the development of clinical trials, as well as oversee the operational aspects of our unit.Main Responsibilities:Lead and manage the Clinical Trials...
-
Packaging and Logistics Coordinator
Vor 5 Tagen
Bern, Bern, Schweiz Pharmiweb VollzeitOur company is committed to excellence in clinical research and development. We are seeking a highly motivated and organized professional to manage and execute clinical trial supplies from setup through to closeout.This role involves coordinating the timely delivery, packaging, distribution, and destruction of clinical trial supplies, ensuring compliance...
-
Clinical Trial Supplies Manager
vor 2 Wochen
Bern, Bern, Schweiz Pharmiweb VollzeitJoin a leading global pharmaceutical company as a Clinical Trial Supply Manager, overseeing the end-to-end supply chain for clinical trials, from planning and packaging to distribution and compliance. This role ensures timely, efficient, and compliant delivery of trial supplies while collaborating with cross-functional teams to support groundbreaking...
-
Quality Assurance Manager
vor 19 Stunden
Muri b. Bern, Bern, Schweiz beBee Careers VollzeitRequirements and QualificationsTo be considered for this Quality Assurance Manager position, you will need to have a Master's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Medicine) and at least 2 years of experience in the medical device industry.You will also need to have experience in preparing and submitting regulatory documents...
-
Quality Manager
vor 2 Wochen
Bern, Bern, Schweiz Universität Bern VollzeitEmployment as of 01.09.2024 or by agreementThe Department of Clinical Research (DCR) is an academic centre and umbrella organization supporting clinical researchers at the University of Bern and the University Hospitals, consisting of a strong Research Unit, the CTU Bern, the Clinical Investigation Unit (CIU) and new future subunits, a Medical Data Science...
-
Technical Program Manager Opportunity
vor 2 Wochen
Bern, Bern, Schweiz Cpl Healthcare VollzeitCpl Healthcare is looking for a Technical Program Manager to lead the development of hardware systems for automated and secure transportation systems. As a Technical Program Manager, you will be responsible for managing a cross-functional team of engineers and optimizing hardware development processes.Key Tasks:Manage a team of engineers in an agile...
-
Clinical Trial Monitor
vor 2 Wochen
Bern, Bern, Schweiz myScience Vollzeit(Senior) Clinical Trial MonitorUniversity of BernPublished 8 April 2025Workplace Bern, Bern region, SwitzerlandCategory HealthPharmacologyPosition Regular Employment / Collaborator(Senior) Clinical Trial Monitor80-100%Department of Clinical Research Employment at the earliest opportunityThe Department of Clinical Research (DCR) is an academic center and...
-
Senior Clinical Research Director
vor 18 Stunden
Bern, Bern, Schweiz beBee Careers VollzeitAbout the RoleWe are seeking a seasoned expert to lead our Clinical Portfolio Execution team, responsible for executing clinical trials and studies. As Director of Clinical Portfolio Execution, you will establish and manage standards and processes for main study operations activities, facilitate global resourcing for clinical portfolio execution roles, and...
-
Clinical Trial Monitor
vor 1 Woche
Bern, Bern, Schweiz University of Bern VollzeitDepartment of Clinical ResearchEmployment at the earliest opportunityThe Department of Clinical Research (DCR) is an academic center and umbrella organization supporting clinical researchers at the University of Bern and the University Hospitals consisting of strong Research Units, the Clinical Trial Unit (CTU), the Clinical Investigation Unit (CIU), and two...
-
Supply Chain Operations Manager
Vor 5 Tagen
Bern, Bern, Schweiz Pharmiweb VollzeitPharmaceutical industry operations require careful planning and execution of clinical trials. We are seeking a skilled professional to manage and execute clinical trial supplies from setup through to closeout.This role involves coordinating the timely delivery, packaging, distribution, and destruction of clinical trial supplies, ensuring compliance with...
-
QA Manager
vor 1 Woche
Bern, Bern, Schweiz TieTalent VollzeitJob DescriptionManage a robust quality management system, ensuring data integrity and subject safety throughout product development from Phase I-III clinical trials to post-marketing.Serve as the primary point of contact for regulatory agencies and other external stakeholders.Develop and implement quality control procedures to ensure compliance with...
-
Senior Regulatory Manager
Vor 7 Tagen
Bern, Bern, Schweiz University of Bern VollzeitOur ExpectationsWe expect the successful candidate to develop and implement regulatory processes to ensure compliance with local, national, and international regulations. This includes leading the preparation and submission of regulatory documents, collaborating with cross-functional teams, and monitoring regulatory developments.The ideal candidate will have...
-
Associate Director, Global Feasibility
vor 4 Wochen
Bern, Bern, Schweiz CSL VollzeitJoining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start-up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...
Clinical-Regulatory Program Manager
vor 4 Wochen
Job Overview
Compremium is seeking a skilled and highly motivated Clinical-Regulatory Program Manager to join our team. The ideal candidate will have a strong background in clinical and regulatory affairs within the medical device sector and experience in regulatory approval pathways with FDA and EU notified bodies. The successful candidate will ensure the compilation of pre-submission and submission packages, prepare pivotal clinical trials and support the continuous interaction with the regulatory authorities.
Join us in our journey and make a meaningful impact on the lives of patients and healthcare professionals
Contact
Please send CV and motivation letter to careers@compremium.ch
Job Responsibilities and Essential Duties:
- Crafting regulatory submissions towards regulatory clearance of Compremium's Class II medical devices in multiple regions, including Breakthrough Designations, FDA pre-subs, 510(k), CE-mark submission.
- Crafting clinical trial submissions for multiple countries to provide strong evidence supporting regulatory clearance.
- Support the continuous interaction with regulatory bodies, preparing interactive discussions, ensuring timely delivery of Q&A packages.
- Perform all work in compliance with the relevant regulations, including ISO 13485, FDA, and EU MDR.
- Provide training and support to staff on clinical and regulatory affairs.
- Stay up to date with changes in regulatory requirements, guidelines, and industry best practices, and advise the organization on potential impacts.
- Cross-functional collaboration: Collaborate with different stakeholders to contribute to company culture and growth.
Requirements:
- Master's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Medicine).
- Experience in the medical device field.
- Experience in preparing and submitting regulatory documents and interacting with regulatory agencies (at least FDA and EU notified bodies).
- Strong experience in designing and preparing medical device clinical trials in the US and Europe.
- Strong understanding of medical device regulations and standards, such as FDA regulations (21 CFR), ISO 13485, and MDR.
- Fast-learning.
- Impeccable English; German and French working proficiency are a plus.
- On-site (in Muri bei Bern) with the possibility of partial remote work.
Required Knowledge, Skills, and Abilities:
- Minimum of 2 years of experience in clinical and regulatory affairs in the medical device industry.
- Excellent understanding of medical device clearance processes with emphasis on regulatory submissions and clinical trials.
- Detail-oriented with a commitment to maintaining high standards of quality.
- Ability to manage time-critical projects.
- Ability to work independently and as part of a team.
- Excellent verbal and written communication skills.
- Ability to work with internationally located collaborators.
- Demonstrates passion and enthusiasm for the company's vision and work.
- Ability to adapt to a changing, fast-paced environment.
About Compremium AG
Compremium is a medical diagnostics company based in Bern, Switzerland. We are on a mission to transform the diagnosis of pressure-related conditions in the human body with our first-of-its-kind, non-invasive platform technology. The device is cleared by the FDA and is currently used by NASA in the International Space Station and other reputed institutions in the United States and Europe. We are in the process of launching our device in the United States, which is our first go to market, with a rapid expansion plan to scale quickly.
Seniority levelEntry level
Employment typeFull-time
Job functionProject Management and Information Technology
IndustriesMedical Equipment Manufacturing
#J-18808-Ljbffr