Regulatory Affairs Manager
vor 3 Wochen
Who we are
You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.
We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.
If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.
Join Sonova. Create sense.
- Staefa, SwitzerlandRegulatory Affairs Manager
- As Regulatory Affairs Manager you are part of the RA team responsible for providing regulatory support and guidance to project teams. You will also be involved early in project development to align on the regulatory strategy and launch planning. You will be responsible for the review of relevant project deliverables, for the monitoring of new and changing regulatory requirements and standards, and for the management of activities and milestones to achieve compliance with changed standards and regulations. You will support with post-market surveillance and vigilance reporting, and directly report to the Director Regulatory Affairs.**Your tasks**
- Preparation of documentation dossiers to achieve timely regulatory approvals and maintenance of the existing portfolio
- Establish and maintain a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing, distribution and surveillance, and regulation of Sonova medical devices and accessories
- Keep abreast of new or changed regulations, guidance documents, and consensus standards in the target markets/regions and communicate relevant changes to the appropriate internal stakeholders
- Work with Legal to ensure compliance with new legal texts in line with effective dates and transition periods
- Review and release of product relevant documentation
- Work closely with product development, marketing, and other teams ensuring strategy falls in line with Regulatory guidelines/requirements through the whole product life-cycle
- Provide guidance on the approval process through EU, MDSAP, and other markets for medical devices and their accessories
- Support post market surveillance activities including process development, planning, scheduling, and timely reporting according to MDR and applicable international requirements
- Update Regulatory knowledge with any new developments within the industry and ensure the implementation into product development strategy, design, manufacturing, and life-cycle efforts
- Support auditing teams, QA team, and team leader when necessary
**Your profile**
- Bachelor's / Master's Degree or equivalent in a technical or scientific field (e.g. Biochemistry, Biomedical, Electrical, or Chemical Engineering), ideally with further education in Engineering, Life Sciences, or Regulatory Affairs
- At least 3-4 years of professional experience in a Regulatory Affairs position in a Medical Device area
- Strong understanding of International regulatory landscape and required approaches/strategies (e.g. USA FDA, Canada, EU)
- Experience of leading Regulatory Affairs submissions
- Experience with monitoring standards and regulation compliance
- Analytical thinking and solution-oriented; driven, enthusiastic, and keen on progressing skills
- Open-minded, objective, trustworthy and reliable teamplayer with excellent communication and interpersonal skills and good work ethics
- Ability to manage time effectively and independently by prioritizing among multiple projects, tasks, and duties
- Fluency in English, both written and spoken
- Excellent MS-Office skills
**Our offer**
- We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles. Employment level 80-100%.- Sonova AG
- Laubisrütistrasse 28
- CH-8712 Stäfa
- +41 58 928 01 01Sonova is an equal opportunity employer.
-
Regulatory Affairs Manager/in
vor 2 Monaten
Zurich, Schweiz Skilled- Recruitment Solutions Vollzeit**Aufgaben**: - Qualitäts - und zulassungsrelevante Dokumenten erstellen, überprüfen und pflegen - Zulassungsdossiers während des gesamten Lebenszyklus pflegen sowie die unterstützende Mitwirkung bei internen Optimierungsprojekten für kommerzielle Produkte - Dokumente zusammenstellen, Projektleistungen für die Registrierungsvorbereitung sowie die...
-
Regulatory Affairs Manager
vor 3 Wochen
Zurich, Schweiz LHH VollzeitFür unseren Mandanten mit Niederlassung im Grossraum Zürich suchen wir einen **Regulatory Affairs Manager (m/w/d)**. Ein familiärer Umgang und eine täglich gelebte Wertschätzung zeichnen das Unternehmen aus. Aufgabengebiet - Mitarbeit in Projektteams und Schnittstelle zu anderen Fachabteilungen hinsichtlich der regulatorischen Anforderungen bei der...
-
Regulatory Affairs Manager
Vor 3 Tagen
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...
-
Regulatory Affairs Cmc Manager
vor 1 Monat
Zurich, Schweiz CSL Behring VollzeitCSL Vifor is a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company. We are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. - Effectively collaborate with technical experts, oversee and direct compilation and update of CMC related dossier components,...
-
Regulatory Affairs Manager
vor 2 Wochen
Zurich, Schweiz Pfizer VollzeitRegulatory Affairs Manager (M/F/d) time type: 60%/80%/100% This is what you can look forward to: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. - Developing...
-
Regulatory Affairs Coordinator
vor 2 Monaten
Zurich, Schweiz Pfizer VollzeitWeltweit arbeiten die Mitarbeiter von Pfizer gemeinsam daran, die Gesundheit eines jeden Einzelnen überall zu verbessern. Während wir Arzneimittel und Medizin-Produkte entwickeln und unser Geschäft global ausweiten, halten wir jederzeit Ausschau nach neuen Talenten. Derzeit suchen wir Sie an unserem Standort in Zürich als: Regulatory Affairs Coordinator...
-
Global Regulatory Affairs Labelling Manager
vor 1 Woche
Zurich, Schweiz CSL Behring VollzeitCSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham,...
-
Regulatory Affairs Manager
Vor 3 Tagen
Zurich, Schweiz ARIAD VollzeitThe Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people. Across the EUCAN BU, patients come first in every decision we make. We develop strategic partnerships which deliver...
-
Regulatory Affairs Manager
vor 3 Wochen
Zurich, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Head Regulatory Affairs Emerging Markets
vor 2 Wochen
Zurich, Schweiz ARIAD Vollzeit**Job ID** R0098443**Date posted** 06/16/2023**Location** Zurich, Canton of Zurich**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic...
-
Head Regulatory Affairs Emerging Markets
Vor 2 Tagen
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic and visionary leader with a strong background in regulatory affairs within the...
-
Head Regulatory Affairs Emerging Markets
vor 2 Wochen
Zurich, Schweiz ARIAD Vollzeit**Job ID** R0098443**Date posted** 06/16/2023**Location** Zurich, Canton of Zurich**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic...
-
Regulatory Affairs Manager
vor 1 Woche
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...
-
Manager Regulatory Affairs 80
vor 2 Monaten
Zurich, Schweiz Adecco VollzeitFür unseren Kunden, ein Unternehmen im Bereich der medizinal-technischen Produktherstellung, suchen wir zum nächst möglichen Zeitpunkt, eine*n **Manager*in Regulatory Affairs 80 - 100 % (w/m/d)** **Ihre Aufgaben** - In der abwechslungsreichen Position als Manager Regulatory Affairs verantwortest Du das Tagesgeschäft im Bereich Regulatory Affairs für...
-
Manager Regulatory Affairs 80
vor 5 Stunden
Zurich, Schweiz Adecco VollzeitFür unseren Kunden, ein Unternehmen im Bereich der medizinal-technischen Produktherstellung, suchen wir zum nächst möglichen Zeitpunkt, eine*n **Manager*in Regulatory Affairs 80 - 100 % (w/m/d)** **Ihre Aufgaben** - In der abwechslungsreichen Position als Manager Regulatory Affairs verantwortest Du das Tagesgeschäft im Bereich Regulatory Affairs für...
-
Director Regulatory Affairs
vor 2 Monaten
Zurich, Schweiz Sonova VollzeitWho we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...
-
Director, Global Regulatory Affairs Cmc
vor 3 Wochen
Zurich, Schweiz Takeda Pharmaceutical VollzeitJoin Takeda as a Director, Global Regulatory Affairs (GRA) CMC, where you will lead GRA CMC Due Diligence in partnership with organizational and external stakeholders. You will ensure the communication/development of regulatory CMC risks and strategy, develop best practices that enable CMC due diligence, ensuring that a given compound meets technical and...
-
Regulatory Affairs
Vor 5 Tagen
Zurich, Schweiz Proclinical VollzeitOur client a global pharmaceutical company specializing in rare diseases, Nephrology and Cardiorenal therapeutic areas is looking to appoint a Regulatory Affairs Labelling manager in their Zurich offices. This is an excellent opportunity to gain global experience within RA labelling in a high performing team at a time when multiple new drug development...
-
Regulatory Affairs Manager Pharma Eu/ch
vor 2 Monaten
Zurich, Schweiz Bernwald Personalberatung 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). **IHRE AUFGABEN**: - Selbständiges Erstellen von CMC-Zulassungsdokumentationen - Termingerechte...
-
Regulatory Affairs Manager Pharma Eu/ch
Vor 4 Tagen
Zurich, Schweiz Bernwald Personalberatung 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). **IHRE AUFGABEN**: - Selbständiges Erstellen von CMC-Zulassungsdokumentationen - Termingerechte...
