Regulatory Affairs Expert

Job Overview:We are seeking a highly skilled Regulatory Affairs Manager to support our rapidly developing Diabetes Care portfolio. This role will be responsible for managing the development and implementation of regulatory strategies, preparing product submission documents for EU and US markets, and partnering with business stakeholders.

Key Responsibilities:Develop and implement regulatory strategies for new and existing productsPrepare and submit product documentation to regulatory authorities in EU and USPartner with business stakeholders to ensure alignment on regulatory requirementsCollaborate with cross-functional teams to ensure compliance with quality management systems (QMS)

Requirements:University degree in Engineering or Natural/Medical Sciences, or equivalent experienceAt least 4 years of professional experience in Regulatory Affairs, with focus on medical devicesExpertise in Active Medical Devices related regulations and guidance documents in EU and USExcellent organizational and people skillsVery good English knowledge...

We are seeking an experienced PV Reporting Expert to join our team at TN Switzerland. As a key member of our Safety Surveillance and Aggregate (SSA) Reports team, you will be responsible for managing processes for all aggregate reports. This is an exciting opportunity for a motivated professional to develop their skills in pharmacovigilance and contribute to...

About the Role:This is an exciting opportunity for a seasoned Regulatory Affairs professional to join our team in Switzerland. As a Regulatory Affairs Manager, you will play a key role in ensuring compliance with medical device regulations, supporting product development, and collaborating with cross-functional teams.

The PV Reporting Expert plays a crucial role in ensuring high-quality standards of PV documents at TN Switzerland. As a team member, you will interact collaboratively and effectively in a team environment, including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory departments. Main Responsibilities:Authoring of aggregate...

Overview of the PositionAs a Regulatory Affairs Expert at TN Switzerland, you will play a key role in supporting the development and implementation of global clinical research projects.Key ResponsibilitiesSupport the development and implementation of global clinical research projects.Collaborate with key opinion leaders, healthcare professionals, and...

As a PV Reporting Expert at TN Switzerland, you will be responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports) in compliance with global PV regulations. You will serve as a subject matter expert on aggregate reporting safety requirements worldwide.Key Responsibilities:Project management and authoring of...

**About the Role:**We are seeking an experienced Senior PV Scientist to join our team as a Global Safety Lead. This individual will be responsible for managing pharmacovigilance activities, leading signal management processes, and collaborating with cross-functional teams.About Experis Switzerland:Experis Switzerland is a trusted partner for businesses...

Senior Downstream ScientistAt Proclinical Staffing, we are seeking a highly skilled Senior Downstream Scientist to join our team. The successful candidate will be responsible for providing technical expertise in downstream process transfer and process sciences.This role involves supporting technology transfer and operations at a drug substance manufacturing...

We are currently looking on behalf of one of our important clients for a Regulatory Affairs Expert. The role is a permanent position based in Solothurn Canton. Your Role: - Carry out tasks to support a rapidly developing digital offering. - Support & prepare product submission documents, with main focus on USA, Canada, China, & the EU. - Prepare regulatory...

At our site in Burgdorf in the field of Regulatory Affairs, we are looking for a personality as a **Regulatory Affairs Manager**: **Ref. No. 4405**: **100%**: **Regulatory Affairs Manager**: **100%**: **Your main tasks**: - Accountable for the definition of regulatory strategies and the preparation of submission documents of reusable pen injector medical...

At our site in Burgdorf in the field of Regulatory Affairs, we are looking for a personality as a **Regulatory Affairs Manager**: **Ref. No. 4405**: **100%**: **Regulatory Affairs Manager**: **100%**: **Your main tasks**: - Accountable for the definition of regulatory strategies and the preparation of submission documents of reusable pen injector medical...

Im Bereich QM & RA in der Abteilung Regulatory Affairs suchen wir am Standort Solothurn in der Schweiz eine technisch versierte Persönlichkeit als **Regulatory Affairs Manager**: **Ref-Nr. 3589**: **100%**: **Regulatory Affairs Manager**: **100%**: **Ihre Hauptaufgaben**: - Fokus von dieser Stelle ist die Unterstützung unserer single-use sterile medical...

In the Business Area Diabetes Care in Solothurn we are looking for an experienced skilled personality as a **Regulatory Affairs Manager | **100%**: Ref. No. 6448 - Location: - Solothurn- | HybridHelp us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach. **Your main...

In the Business Area Diabetes Care we are looking in Solothurn for an experienced skilled personality as a **Regulatory Affairs Manager **| 80 - 100%**: Ref. No. 6142 - Location: - SolothurnSupport us in the production and development of cutting-edge medical technology solutions that enable people around the world to self-manage diabetes and other chronic...

Focus of this position:Supporting our rapidly developing Diabetes Care (active and connected devices)Manage the development and implementation of regulatory strategiesSupport and prepare product submission documents with main focus on EU and USPartner with business stakeholders on different levelsCommunication and correspondence with authoritiesCooperation...

Für unseren Mandanten, ein weltweit agierendes Pharmaunternehmen mit flachen Hierarchien und einem familiären Miteinander sucht zum nächstmöglichen Zeitpunkt einen **Medical Affairs Scientist (m/w/d)**. Das Unternehmen hat sich zum Ziel gesetzt, die Gesundheit der Menschen weltweit durch stetige Weiterentwicklungen von Arzneimitteln und Medizinprodukten...

Sr. Manager, Corporate Affairs, Rare Disease Communications (BBBH611026) Solothurn, Switzerland The Sr. Manager/Manager, Rare Disease Communications, is accountable for supporting the Rare Disease Corporate Affairs Lead in the development and implementation of an integrated rare disease communications strategy that encompasses internal and external...

Sr. Manager, Corporate Affairs, Rare Disease Communications (BBBH611026) Solothurn, SwitzerlandThe Sr. Manager/Manager, Rare Disease Communications, is accountable for supporting the Rare Disease Corporate Affairs Lead in the development and implementation of an integrated rare disease communications strategy that encompasses internal and external...

Social network you want to login/join with:Sr. Manager, Corporate Affairs, Rare Disease Communications, SolothurnClient:ExperisLocation:SwitzerlandJob Category:OtherJob Reference:0c8db798062eJob Views:2Posted:14.03.2025Expiry Date:28.04.2025Job Description:The Sr. Manager/Manager, Rare Disease Communications, is accountable for supporting the Rare Disease...

In the Quality Management, Regulatory & Medical Affairs area in the Quality Assurance department, we are looking for a customer-oriented and quality-conscious personality in the Production Management Team at the Solothurn site as a **Quality Assurance Manager **| 80 - 100%**: Ref. No. 6219 - Location: - Solothurn- | HybridHelp us bring to market...

Kraftort.Ypsomade. Zur Verstärkung suchen wir im Bereich Quality Management, Regulatory & Medical Affairs am Standort Solothurn eine erfahrene und kompetente Persönlichkeit alsQMS Application Manager| - %Ref-Nr. 9 Arbeitsort: Solothurn |Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu bringen, indem Sie dank Ihrer strukturierten...

The Aggregate Reports PV Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports).The Aggregate Reports PV Scientist serves as a subject matter expert on aggregate reporting safety requirements worldwide for the PV Scientist...

Social network you want to login/join with:Aggregate Report PV Scientist, SolothurnClient: ExperisLocation: SolothurnJob Category: OtherJob Reference: d8e1d8db6589Job Views: 4Posted: 14.03.2025Expiry Date: 28.04.2025Job Description:The Aggregate Reports PV Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for...

Senior PV Scientist serves as a global product lead for Pharmacovigilance activities within the Safety department including managing PV Scientist(s) assigned to products within the Senior PV Scientist's designated products.Key Responsibilities:Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating...

Social network you want to login/join with:Senior PV Scientist serves as a global product lead for Pharmacovigilance activities within the Safety department including managing PV Scientist(s) assigned to products within the Senior PV Scientist's designated products.Key Responsibilities:Leads the signal management process (i.e., signal detection, signal...

Kraftort.Ypsomade. Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Solothurn eine kundenorientierte und qualitätsbewusste Persönlichkeit alsQuality Assurance Manager| - %Ref-Nr. 7 Arbeitsort: Solothurn , Burgdorf |Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu...

Senior PV Scientist serves as a global product lead for Pharmacovigilance activities within the Safety department including managing PV Scientist(s) assigned to products within the Senior PV Scientist's designated products.Key Responsibilities:Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating...

Social network you want to login/join with:Clinical Research & Evaluation Manager, SolothurnClient: YpsomedLocation: SolothurnJob Category: OtherJob Reference: 90956b1906f3Job Views: 10Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Responsible for overseeing global clinical trials, ensuring compliance with ISO, the Declaration of Helsinki, and...