Term állások, munkák egészségügy, gyógyszeripar területen

As a medical physicist, you will be responsible for operating imaging devices in both clinical and research contexts. Ensuring safety in handling radioactive materials and the use of X-rays is a primary responsibility, and an appointment as radiation protection officer is foreseen. A major function...

Lead the development and continuous evolution of the German TMTT marketing strategy, ensuring alignment with the European vision while tailoring approaches to local market dynamics, regulatory frameworks, and unmet clinical needs....

Supporting the advanced development team on a variety of projects that entail design, manufacturing, and testing of prototypes necessary to arrive at proof of concept for a novel eye implant technology...

Lead Expert Quality Assurance, Deputy Responsible Person 40%Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing...

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

• Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
• Preparation, review, and approval of all relevant study documents in collaboration with external service providers

• Implement and validate state-of-the-art sequencing technologies (short-read and long-read) for diverse medical and scientific applications
• Establish and further develop an innovative metagenome sequencing platform for clinical diagnostics and hospital hygiene

Project Management and Leadership: As an Embedded Software Project Lead, you will oversee the planning, execution, monitoring and delivery of embedded software projects for innovative medical devices for applications in ophthalmology. You will ensure projects are completed on time, within budget,...

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

Management of projects from conception, development work, verification, manufacturing, validation and ultimately product commercialization, in accordance with Hygiena's Product Commercialization Process (PCP)....

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...