Regulatory Affairs Coordinator

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...

About the TeamWe are a successful, rapidly growing company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world.Key ResponsibilitiesDevelop and implement strategies to engage with patient communities and advocacy groups.Establish and maintain relationships with key opinion leaders, healthcare professionals, and...

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...

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...

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...

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...

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...

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...

Are you great at organizing knowledge and connecting dots? Do you enjoy having things in order and assuring that everything makes perfect logical sense? Are you the kind of person who is ready to find solutions to complex problems and stays level-headed when request pile up? Would you like to use these skills to improve lives of cancer patients at the...

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...

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...

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...

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: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...