Regulatory & Clinical Affairs Expert
Vor 2 Tagen
Our customer is a leading Swiss SME and developer of cutting edge High-Tech Medical Device technology. A disruptor in their field with a strong Engineering core originating at Bern University, though now employing some of the brightest minds in Electronics, Mechatronics, physics and Software development. We have been tasked to identify and recruit a Regulatory & Clinical Affairs Expert to join their team in Bern, Switzerland.
**Your mission**:
- Establish and maintain technical documentation and device classifications for medical navigation systems.
- Prepare and submit documentation describing the device’s performance characteristics.
- Write clinical evaluation reports for regulatory submission.
- Review relevant literature related to global medical device regulations.
**Your profile**:
- Five years of professional experience with medical navigation and/or surgical robotic systems.
- Education in Engineering or Life Sciences.
- Excellent English writing skills - clear, structured, and concise.
- Proficient in using MS Word and information management tools.
- Strong interpersonal and superior communication skills.
-
Vice President, Head of Regulatory Affairs
vor 1 Woche
Bern, Schweiz NonStop Consulting VollzeitOn behalf of a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition we are currently looking for a Vice President, Head of Regulatory Affairs for their Biosimilars BU. **Activities**: Responsible for directing global regulatory strategies for assigned projects and...
-
Global Regulatory Affairs Manager Cmc Gene Therapy
vor 2 Wochen
Bern, Schweiz We make it VollzeitBeschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...
-
Regulatory Affairs Manager
Vor 3 Tagen
Bern, Schweiz Sigma VollzeitI’m currently searching for a Regulatory Affairs Manager for one of my clients, a company specializing in the development and distribution of medical devices on a global scale. **Main responsibilities**: Maintain Technical documentation of all products. Registration of new products. Keeping up to date with changes in regulatory legislation and...
-
Regulatory Affairs Consultant
vor 2 Wochen
Bern, Schweiz Parexel VollzeitAre you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team!The role can be home or office based in various European locations.Key...
-
Global Regulatory Affairs Manager Cmc Gene Therapy
vor 2 Wochen
Bern, Schweiz We make it GmbH VollzeitWe make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest...
-
Regulatory Affairs Consultant
vor 2 Monaten
Bern, Schweiz Parexel VollzeitAre you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team! The role can be home or office based in various European...
-
Support Regulatory Affairs
vor 2 Wochen
Bern, Schweiz We make it VollzeitBeschreibung: We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest...
-
Assistant Regulatory Affairs
vor 2 Wochen
Bern, Schweiz We make it VollzeitBeschreibung: We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest...
-
Clinical Trial Manager
vor 7 Monaten
Bern, Schweiz InnoMedica Holding AG Vollzeit**INNOMEDICA IS A YOUNG NANOTECH COMPANY **with 50 employees, a number of promising drugs in preclinical and clinical development and its own clean room production. in the fields of oncology (gentle chemotherapy) and neurology (new approach to treat Parkinson's disease). In order to conduct further clinical trials with our Clinical Research Team based in...
-
Global Regulatory Affairs Digitalization Lead
vor 2 Wochen
Bern, Schweiz CSL Behring VollzeitCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, haematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Global Regulatory Affairs...
-
Global Regulatory Affairs Cmc Scientist in The
vor 7 Monaten
Bern, Schweiz CSL Behring VollzeitDo you want to work in a global team and support worldwide registrations for Albumins? The Global Regulatory Affairs CMC Scientist is part of a global team of eight responsible for over 150 Albumins licenses in almost 100 countries worldwide. Albumin is manufactured at four CSL Behring sites and contributes significantly to the companies’ revenue. The...
-
Regulatory Affairs Manager
vor 5 Monaten
Bern, Schweiz pharma-jobs24.ch VollzeitSie möchten Ihre Expertise gezielt in einer neuen beruflichen Herausforderung unter Beweis stellen, um Ihr Potential voll ausschöpfen zu können? Dann gehen Sie jetzt mit uns Ihren nächsten Karriereschritt!bruederlinpartner bringt als spezialisierter Personaldienstleister jeden Tag Fach- und Führungskräfte mit nationalen und internationalen Unternehmen...
-
Clinical Trial Manager
Vor 2 Tagen
Bern, Schweiz InnoMedica Holding AG Vollzeit**INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...
-
Director, Sr. Global Regulatory Lead, Hematology Ta
vor 13 Stunden
Bern, Schweiz CSL Behring Vollzeit**Position Purpose**: The Dir., Sr. Global Regulatory Lead, Hematology TA, is a member of a GRA GPS Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as: - ** GRA** Representatives** **on Product/Project Strategy Teams (PSTs), key Delivery Teams (e.g., Clinical Development Teams [CDTs], Safety Management Teams...
-
Support Regulatory Affairs
vor 2 Wochen
Bern, Schweiz We make it GmbH VollzeitWe make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for...
-
Mitarbeiter Regulatory Affairs
Vor 2 Tagen
Bern, Schweiz Air Liquide Vollzeit**Unternehmenspräsentation** AIR LIQUIDE** ist ein Weltmarktführer bei Gasen, Technologien und Services für Industrie und Gesundheit. Mit rund 66.400 Mitarbeitern in 75 Ländern versorgt Air Liquide mehr als 3,8 Millionen Kunden und Patienten. Sauerstoff, Stickstoff und Wasserstoff sind kleine Moleküle von grundlegender Bedeutung für das Leben, für die...
-
Senior Director Regulatory Group Lead
vor 4 Wochen
Bern, Schweiz CSL Plasma VollzeitCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
-
Global Regulatory Affairs Manager Cmc
vor 2 Wochen
Bern, Schweiz Hays Vollzeit**My duties** - Maintenance of the content of relevant parts of the regulatory dossiers. - Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs)and lifecycle submissions - Provide timely and high quality answers to CMC-related questions from...
-
Regional Regulatory Lead
Vor 3 Tagen
Bern, Schweiz CSL Behring VollzeitThe Regional Regulatory Representative is responsible for all regional regulatory strategic and operational tasks for a range of products in the assigned Therapeutic Areas (TA) and Intercontinental (ICO) Region (Latin America, Eastern Europe (non-EU), Middle East and Africa). In consultation with the Therapeutic Area Lead, Regional Regulatory Lead...
-
(Junior) Chemiker Regulatory Affairs
Vor 4 Tagen
Bern, Schweiz Batterman Consulting Basel AG VollzeitDie Dr. E. Graeub AG ist ein traditionsreiches Schweizer Pharmaunternehmen und führend auf dem Gebiet der Tiermedizin. Das Produktportfolio umfasst Pharmazeutika, Biologika und Futtermittel. Am Firmensitz in Bern werden eigene Produkte entwickelt, produziert und vertrieben. Ergänzt wird das Spektrum durch einlizensierte Produkte internationaler Firmen. Als...