Quality and Regulatory Lead for Medical Device Innovation
vor 1 Tag
About Odne AG
We are a pioneering medical device startup dedicated to revolutionizing the endodontic device market. Founded in 2018 and ISO 13485 certified, our mission is to develop groundbreaking solutions that help people preserve their natural teeth.
Job OverviewAs a Quality and Regulatory Manager, you will be responsible for spearheading our quality management system and ensuring compliance with regulatory requirements.
The ideal candidate will have a strong background in science or engineering, with at least 5 years of experience in the medical device industry in a quality or Q&R position.
Key Responsibilities- Maintain and improve our QMS according to ISO 13485 & 21 CFR 820 standards.
- Serve as a Management Representative and Person Responsible for Regulatory Compliance (PRRC).
- Manage non-conformities, change control, CAPAs, complaints, feedback, vigilance, and medical device reporting activities.
- Plan, conduct, monitor, and evaluate management reviews, trainings, and audits (internal & supplier).
- Foster collaboration with our notified body, the FDA, and other authorities.
- Background in science or engineering and at least 5 years of work experience in the medical device industry in a quality or Q&R position.
- Thorough experience in setting up and maintaining a quality management system for medical devices is a must.
- Expert knowledge and hands-on experience of applicable norms and regulations: EU MDR, ISO 13485, 21 CFR 820, ISO 14971.
- Ability to create documentation efficiently.
- High IT-proficiency; experience with MS SharePoint, MS Access, SQL, and/or PowerApps is a plus.
We offer a dynamic startup environment, high responsibility, and room for personal development and learning. Our young, international team of 10 people is enthusiastic and motivated to achieve our mission.
-
Dübendorf, Zürich, Schweiz Odne AG VollzeitAbout Odne AGA dynamic MedTech startup founded in 2018, ISO 13485 certified, aiming to revolutionize the endodontic device market in the US and EU.Job Description: Senior Regulatory Affairs and Quality Assurance ManagerWe are seeking an experienced professional to oversee regulatory affairs and quality assurance, ensuring compliance with FDA and MDR...
-
Dübendorf, Zürich, Schweiz Moovimenta AG VollzeitMoovimenta AG is a Swiss-based family-owned organization with a strong presence in the global market. With revenues exceeding 850 million CHF and over 5000 employees, we have established ourselves as a leading player in our industry.The company comprises four Divisions: Habasit, Rossi, NGI, and TRAPO, which work together to deliver innovative products and...
-
Dübendorf, Zürich, Schweiz EMPA VollzeitPostdoctoral Researcher in the Field of Advanced MaterialsWe are seeking a highly motivated and experienced materials scientist to join our team at Empa, a leading research institution in the ETH Domain. As a postdoctoral researcher, you will be working on the development of stimuli-responsive polymer nanocomposites with multiple functionalities.About the...
-
Scientist for Stimuli-Responsive Polymer Materials
vor 2 Wochen
Dübendorf, Zürich, Schweiz EMPA VollzeitResearch Scientist Opportunity in Advanced Polymer NanocompositesAt Empa, a leading research institution of the ETH Domain, we are passionate about materials science and technology. Our team is dedicated to creating innovative solutions for a sustainable future.We are currently seeking a highly motivated and experienced researcher for a postdoctoral position...
-
Industrial Operations Management Trainee
vor 2 Wochen
Dübendorf, Zürich, Schweiz Givaudan VollzeitAbout Givaudan: A Global Leader in Fragrance & Beauty and Taste & WellbeingGivaudan is a global leader in Fragrance & Beauty and Taste & Wellbeing. We celebrate the beauty of human experience by creating for happier, healthier lives with love for nature. Our mission is to deliver food experiences, craft inspired fragrances, and develop beauty and wellbeing...
-
Transformational Product Development Leader
Vor 2 Tagen
Dübendorf, Zürich, Schweiz Moovimenta AG VollzeitAbout UsMoovimenta AG is a Swiss-based, family-owned organization with a strong presence in the industrial intra-logistics sector. With revenues exceeding 850M CHF and a workforce of over 5000 employees, we have established ourselves as a leading player in this domain.Our MissionWe are dedicated to innovating transportation solutions that take our industry...
-
Safety Expert for Air Traffic Management
vor 1 Woche
Dübendorf, Zürich, Schweiz skyguide VollzeitJob DescriptionYour mission is to provide assistance in the conduct of safety activities relating to change management within Skyguide.We are looking for a team member who has a clear commitment to the primacy of safety and can apply defined safety procedures and regulations.Conduct safety activities according to the Safety Assessment Processes for technical...
-
Dübendorf, Zürich, Schweiz Moovimenta AG VollzeitMarketing and Communication Specialist RoleWe are seeking an experienced Marketing and Communication Specialist to join our team at Moovimenta AG. As a marketing professional, you will be responsible for designing and implementing marketing plans across multiple projects, sourcing suppliers, creating content, and collaborating with freelancers and...
-
Dübendorf, Zürich, Schweiz EMPA VollzeitAt EMPA, we are seeking a highly motivated and innovative Postdoctoral Researcher to join our Cellulose & Wood Materials Laboratory. The ideal candidate will have a strong background in materials science, chemistry, or a related field, with a focus on polymer formulations and nanocomposites.Role OverviewWe are looking for a talented researcher to develop...
-
Technical Solution Specialist
Vor 2 Tagen
Dübendorf, Zürich, Schweiz Moovimenta AG VollzeitWe are a diverse team of engineers and business developers working on a multitude of innovative products and technology projects with the mission to take transport in industrial intra-logistics to the next level.Our collaborative and empowering environment fosters a culture where your ideas will be valued, and your potential will be unleashed. We are seeking...
-
Product Launch Marketing Strategist
vor 2 Wochen
Dübendorf, Zürich, Schweiz Moovimenta AG VollzeitMoovimenta AG, a leading Swiss-based organization with a strong presence in the global market, is seeking an experienced Product Launch Marketing Strategist to drive the go-to-market campaign for a new product emerging from its Corporate Accelerator in Zurich. The ideal candidate will bring expertise in designing and implementing marketing and communication...
-
Operations Leadership Development Initiative
vor 2 Wochen
Dübendorf, Zürich, Schweiz Givaudan VollzeitAbout the Operations Leadership ProgramGivaudan, a global leader in Fragrance & Beauty and Taste & Wellbeing, is seeking highly skilled professionals for its Operations Leadership Program. As part of this program, you will gain valuable insights into different departments within Givaudan's operational functions.Throughout the 18-24 month program, you will...
-
Construction Liability Expert with a Global Perspective
vor 2 Monaten
Dübendorf, Zürich, Schweiz Helvetia VollzeitWe are seeking an experienced Construction Liability underwriter to join our team at Helvetia Specialty Lines in Zurich. With a strong focus on long-term sustainability and profitability, this role offers the opportunity to develop a deep understanding of the global construction liability market.About UsHelvetia Specialty Lines is a leading provider of...
-
Construction Liability Underwriter
vor 4 Wochen
Dübendorf, Zürich, Schweiz Helvetia VollzeitAre you ready to take your underwriting career to the next level? We're looking for a skilled Construction Liability Underwriter to join our team in Zurich.About HelvetiaHelvetia is a leading insurance company with a rich history and a strong presence in the Swiss market. Our Specialty Lines division offers a range of innovative insurance solutions for...
-
Air Traffic Safety Management Specialist
vor 2 Wochen
Dübendorf, Zürich, Schweiz skyguide Vollzeit**Company Overview:**Skyguide is a leading provider of air traffic management solutions, and we are seeking an experienced professional to join our safety division team.We offer a competitive salary range from CHF 90,000 to CHF 110,000 per year, depending on experience and qualifications.**Job Description:**In this role, you will assist in the conduct of...
-
Air Traffic Management Safety Specialist
vor 2 Wochen
Dübendorf, Zürich, Schweiz skyguide VollzeitAbout SkyguideSkyguide is a leading provider of air traffic management services, committed to ensuring the safety and efficiency of flight operations.Job SummaryWe are seeking an experienced Air Traffic Management Safety Specialist to join our team. As a key member of our safety division, you will play a crucial role in promoting a safety-first culture...
-
Aviation Safety Professional
vor 2 Wochen
Dübendorf, Zürich, Schweiz skyguide VollzeitAbout SkyguideSkyguide is a leading provider of air traffic management services, committed to ensuring the safety and efficiency of aviation operations.Job DescriptionWe are seeking an experienced Aviation Safety Professional to join our team as a Safety Technical Investigator. This role plays a vital part in maintaining and enhancing aviation safety by...
-
Dübendorf, Zürich, Schweiz EMPA VollzeitWe are passionate about materials science and technology, and we make essential contributions to the well-being of society with our cutting-edge research. Our team is looking for a highly motivated individual to join our Cellulose & Wood Materials Laboratory as a postdoctoral researcher in the field of stimuli-responsive polymer nanocomposites.Job...
-
Safety Aviation Risk Specialist
vor 2 Wochen
Dübendorf, Zürich, Schweiz skyguide VollzeitAt Skyguide, we are committed to maintaining and enhancing aviation safety through proactive measures.As a Safety Aviation Risk Specialist, you will play a vital role in analysing incidents, proposing preventive measures, and fostering a culture of safety within our organisation. If you have a passion for safety and the skills to contribute to our mission,...
-
Aviation Safety Professional
vor 2 Wochen
Wangen b. Dübendorf, Zürich, Schweiz Skyguide VollzeitSystem Safety Expert Job DescriptionSkyguide provides air navigation services in Switzerland and neighbouring countries, employing over 1,500 staff from more than 30 nations. The company pursues an ambitious innovation strategy based on a strong safety and learning culture.Your Mission:As part of the safety division team, you will assist in conducting safety...