Regulatory Affairs Manager
vor 11 Stunden
Présentation:
Workload: 80 - 100%
Place of work: Fällanden, Switzerland
Department: Quality and Regulatory Affairs
Start of contract: Immediately or by agreement
Responsabilités:
- Team member in a team of 5 Regulatory Affairs professionals, positioned in several countries, with Production Sites close to Zurich CH (manufacturer site), Karlsruhe GER and Strasbourg FR (some travel required; remote work option with 2 days out of 5 home office)
- IVD (e.g., EU IVDR) compliance roll out in an international analytical instrumentation life sciences company - from approval process (e.g., TechDoc review) to day-to-day support of internal stakeholders (e.g., for performance studies) and execution of UDI implementation, multi-country registrations and post-market-surveillance activities.
- Ensure international product compliance of medical devices (IVDs) in a pro-active and pragmatic, but always compliant way
Qualifications:
- Academic degree in a relevant field
- Proven multi-year experience in the medical device (MD or IVD) or life sciences industry in the field of quality and/or regulatory affairs
- Proven project management skills, international and cross-country exposure a plus
- Fluent in English including presentation and trainer skills, German and/or French a plus
- Ability to interact and align with various stakeholders - from Board level to peer groups
- Strong track record in prioritizing and simultaneously managing and/or supporting multiple IVD-related projects in a fast-paced environment
**What we offer**
- Home office possibility with 41.5 hours per week
- Future-oriented and diverse company with modern workplaces
- At least five weeks of vacation and additional days off
- Free parking garage on the company premises
- Cost absorption of the SBB Half-Fare Card
- Good social benefits and insurance
- Diverse opportunities for further development in Switzerland and globally
- Promotion of health and sports with various initiatives and an in-house fitness studio
- Work location with local recreation area (Greifensee)
- Our staff restaurant "Food Spin" with freshly prepared menus and buffet every day
**Who we are
-
Regulatory Affairs Manager
vor 1 Tag
Basel, Schweiz LHH VollzeitWe have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel. As a Regulatory Affairs Manager, you will be responsible for: - Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) - Lead...
-
Manager, Regulatory Affairs
Vor 3 Tagen
Basel, Schweiz Lonza VollzeitTitle: Manager, Regulatory Affairs (CMC)Hybrid working pattern: 2 WFHLocation: Basel or VispRelocation support is provided – subject to criteria.Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working...
-
Regulatory Affairs Manager
vor 1 Woche
Basel, Schweiz Sandoz Vollzeit**Regulatory Affairs Manager, Novartis, Basel, Switzerland** 1 unique opportunity to join Regulatory Affairs Team! Person on this position will take care of all drug regulatory affairs matters regarding the assigned indication group. Acts as an interface between global Regulatory Affairs departments and Swiss medic in order to obtain new marketing...
-
Basel, Schweiz DSM Vollzeit**DSM - Bright Science. Brighter Living.** **What you’ll do**: - As a Regulatory Affairs Manager, you will manage the regulatory compliance, market clearance, advocacy and business support of DSM animal nutrition products and provide advice to Marketing and Sales, Product Management, Global Regulatory in all regulatory related topics/issues for Animal...
-
Regulatory Affairs Manager
Vor 5 Tagen
Basel, Schweiz Proclinical VollzeitProclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Offer regulatory assistance for projects and project teams. - Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical...
-
Basel, Schweiz Sobi Vollzeit**Manager, Regulatory Affairs, International** One of Sobi’s four strategic pillars is to “Go Global”. The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio into new territories and to register several of our development projects into the...
-
REGULATORY AFFAIRS PROJECT MANAGER
Vor 4 Tagen
Basel, Schweiz Alira Health VollzeitJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Regulatory Affairs Manager
vor 1 Woche
Basel, Schweiz CTC Resourcing Solutions Vollzeit**The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...
-
Regulatory Affairs Manager
Vor 7 Tagen
Basel, Schweiz Boehringer Ingelheim VollzeitInnovative Medikamente für Mensch und Tier: Dafür steht das forschungsbasierte Pharmaunternehmen Boehringer Ingelheim seit über 130 Jahren. Boehringer Ingelheim zählt zu den 20 führenden Unternehmen der Branche und ist auch heute noch ein Familienunternehmen. Jeden Tag schaffen rund 52.000 Mitarbeiter Werte durch Innovation in den drei...
-
Regulatory Affairs Coordinator
Vor 2 Tagen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**Regulatory Affairs Coordinator 4881 SRS** As the Regulatory Affairs Coordinator you will support the Regulatory team in managing, tracking and archiving regulatory requests received from our partners companies in their respective territories. **Main Responsibilities**: - Ensuring all documents/declarations/statements are signed by company...
-
Regulatory Affairs Manager
Vor 4 Tagen
Basel, Schweiz Pharma-Jobs24 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...
-
Quality Assurance
Vor 2 Tagen
Basel, Schweiz ALTOGEN AG Vollzeit**Quality Assurance & Regulatory Affairs (QA/RA) Manager - Medical Devices** ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas...
-
Regulatory Affairs Manager
Vor 4 Tagen
Basel, Schweiz Boehringer Ingelheim GmbH VollzeitInnovative Medikamente für Mensch und Tier: Dafür steht das forschungsbasierte Pharmaunternehmen Boehringer Ingelheim seit über 130 Jahren. Boehringer Ingelheim zählt zu den 20 führenden Unternehmen der Branche und ist auch heute noch ein Familienunternehmen. Jeden Tag schaffen rund 52.000 Mitarbeiter Werte durch Innovation in den drei...
-
Regulatory Affairs Manager Pharma Eu/ch
Vor 2 Tagen
Basel, Schweiz Bernwald Personalberatung GmbH VollzeitUnsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat. In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d). **Arbeitsort**: Grossraum Zürich Aufgaben - Selbständiges Erstellen von...
-
Regulatory Affairs Manager 100%
vor 1 Woche
Basel, Schweiz Global Personal Partner Vollzeit**EINFÜHRUNG**: Our profession and our passion are "HR Management". Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of services in the field of Human Resources at 21 locations in German-speaking Switzerland. For our client, an international technology company in Basel, we are looking...
-
Regulatory Affairs Associate Director, Europe
vor 1 Woche
Basel, Schweiz BeiGene VollzeitREGULATORY AFFAIRS Associate Director, Europe (with focus on Switzerland) Regulatory Affairs, Basel, Switzerland Reports To: Director, Team Lead of EU Regulatory Affairs **Job Description**: The (Swiss) Regulatory Affairs lead will report to the team lead of Regulatory Affairs Europe and will have dotted line reporting to the Swiss General Manager. The...
-
Regulatory Affairs Manager
Vor 4 Tagen
Basel, Schweiz Corza Medical VollzeitLocation: role can be located anywhere in Europe At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves. Our product family is the result of years of experience championing surgeons and...
-
Drug Regulatory Affairs Manager 80-100%
vor 21 Stunden
Basel, Schweiz Gi Group SA VollzeitFür das Unternehmen unseres Kunden in Basel suchen wir einen Drug Regulatory Affairs Manager 80-100% Tasks: Selbständige Erstellung und Pflege von Zulassungs- und Registrierungsdossiers für unsere Arzneimittel, mit Fokus auf präklinische (Toxikologie und Sicherheit) und klinische DokumentationErarbeitung der entsprechenden Dokumentationen im Rahmen...
-
Senior Regulatory Affairs Consultant
Vor 4 Tagen
Basel, Schweiz Arcondis Group VollzeitLocations: Switzerland (optional in Germany, Slovakia, Singapore, USA)Contract: PermanentCompany and job overviewARCONDIS is a global consulting company with an exclusive focus on the healthcare and life science industries, managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital...
-
Regulatory Affairs Manager
Vor 3 Tagen
Basel, Schweiz CTC Resourcing Solutions VollzeitThe Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Our client, a global market leader in the production and process...