Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Professional - Lausanne, Waadt - MedTech Innovator
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Regulatory Affairs Expert
Vor 3 Tagen
Lausanne, Waadt, Schweiz Intuitive Surgical VollzeitAt Intuitive Surgical, we're dedicated to advancing minimally invasive care. As a pioneer in robotic-assisted surgery, we strive to foster an inclusive and diverse team committed to making a difference.Job OverviewThe Senior Regulatory Affairs Specialist plays a critical role within the Regulatory Affairs Department, focusing on providing advanced regulatory...
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Regulatory Affairs Specialist
vor 17 Stunden
Lausanne, Waadt, Schweiz Michael Page International (Switzerland) SA VollzeitAbout Our ClientOur client is a leading organization in the Life Sciences sector, renowned for its innovative work and commitment to improving lives worldwide.Job OverviewEnsure regulatory compliance with relevant standards.Develop and implement process improvements.Collaborate with cross-functional teams to deliver projects on time and within budget.Provide...
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Regulatory Affairs Expert
Vor 2 Tagen
Lausanne, Waadt, Schweiz Intuitive VollzeitJob OverviewWe are seeking a seasoned Senior Regulatory Affairs Specialist to join our team at Intuitive. This role plays a critical part in providing advanced regulatory support for New Product Development (NPD) and sustaining operations across designated Business Units.Key ResponsibilitiesLead regulatory efforts in NPD projects and sustaining activities,...
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Senior Regulatory Affairs Specialist
Vor 2 Tagen
Lausanne, Waadt, Schweiz Intuitive VollzeitAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a...
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Senior Regulatory Professional
Vor 2 Tagen
Lausanne, Waadt, Schweiz Intuitive VollzeitResponsibilities and RequirementsThis Senior Regulatory Affairs Specialist role requires a strong background in EU regulations and directives, as well as experience managing regulatory submissions and compliance activities. The ideal candidate will have a minimum of 8+ years of experience in regulatory affairs within the medical device industry, with...
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Regulatory Affairs Strategist
Vor 2 Tagen
Lausanne, Waadt, Schweiz Distalmotion SA VollzeitAbout the RoleDistalmotion SA is seeking a highly skilled Regulatory Affairs Specialist to lead substantial and complex regulatory projects. This role will work closely with management to establish the overall strategic direction for Regulatory Affairs and collaborate across multiple internal departments as well as external regulatory and governing bodies to...
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Regulatory Affairs Specialist
Vor 2 Tagen
Lausanne, Waadt, Schweiz Distalmotion SA VollzeitJoin Us in Empowering Access to Robotic SurgeryAt Distalmotion, we believe patients deserve best-in-class minimally invasive care. Our mission is to empower access to the benefits of robotic surgery. The DEXTER Robotic Surgery System uniquely simplifies operations so more surgeons, in more ORs, can provide the benefits of robotics to more patients.Whether in...
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Senior Regulatory Professional
Vor 3 Tagen
Lausanne, Waadt, Schweiz Intuitive Surgical VollzeitWe're passionate about making a difference through minimally invasive care. Our team members are grounded in integrity, have a strong capacity to learn, and bring diverse, real-world experiences to help us think in new ways.Job DescriptionThe Senior Regulatory Affairs Specialist will play a key role in providing advanced regulatory support for NPD and...
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Regulatory Affairs Specialist
vor 1 Woche
Lausanne, Waadt, Schweiz MedTech Innovator VollzeitAbout usAt Distalmotion, we believe that every patient undergoing minimal invasive surgery should benefit from the best of surgical expertise and robotic technology. This is the vision that made us create Dexter, the world's first and only on-demand robotic surgery system. Thanks to Dexter, surgeons have never been closer to their patients while benefiting...
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Global Regulatory Affairs Lead
Vor 3 Tagen
Lausanne, Waadt, Schweiz SICPA VollzeitResponsibilities:The Principal Product Compliance Scientist at SICPA is responsible for:Developing and implementing regulatory strategies to ensure compliance with relevant regulations.Providing regulatory guidance and support to cross-functional teams.Collaborating with R&D teams to develop innovative products that meet regulatory requirements.Ensuring...
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Regulatory Affairs Manager
vor 17 Stunden
Lausanne, Waadt, Schweiz Wyss Center for Bio and Neuroengineering VollzeitThe Wyss Center for Bio and Neuroengineering invites applications from experienced Regulatory Affairs Managers who can ensure compliance with regulatory requirements in our clinical trials.Responsibilities:Regulatory Compliance: Ensure that all our projects are conducted in accordance with relevant laws and regulations.Agreement Review and Assessment: Review...
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Global Regulatory Expert
vor 17 Stunden
Lausanne, Waadt, Schweiz Michael Page International (Switzerland) SA VollzeitWe are looking for a highly skilled Regulatory Affairs Engineer to join our team at Michael Page International (Switzerland) SA.Responsibilities include:Ensuring regulatory compliance with all relevant standards.Developing and implementing process improvements.Collaborating with cross-functional teams to deliver projects on time and within budget.Providing...
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Global Regulatory Coordinator
Vor 2 Tagen
Lausanne, Waadt, Schweiz Distalmotion SA VollzeitJob DescriptionThe Regulatory Affairs Specialist will be responsible for leading substantial and complex regulatory projects, collaborating with management to establish the overall strategic direction for Regulatory Affairs, and ensuring our products and services meet the needs of our patients, customers, regulators, and remain compliant with our internal...
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Medical Device Regulatory Lead
Vor 2 Tagen
Lausanne, Waadt, Schweiz Intuitive VollzeitJob DescriptionThe Senior Regulatory Affairs Specialist will play a crucial role in supporting the success of product launches and ongoing operations. Key responsibilities include leading regulatory efforts in NPD projects and sustaining activities, acting as a lead contact for Notified Bodies, and managing the preparation, submission, and maintenance of EU...
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Regulatory Affairs Coordinator
Vor 2 Tagen
Lausanne, Waadt, Schweiz Debiopharm VollzeitThe Role:As a Medical Writer at Debiopharm, you will play a crucial role in the development of high-quality clinical and regulatory documents for global clinical studies, primarily in oncology programs. Your primary responsibility will be to create documents that meet international requirements and comply with ICH GCP standards.Key aspects of your job will...
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Regulatory Affairs Specialist
Vor 2 Tagen
Lausanne, Waadt, Schweiz ONWARD (GTX Medical) VollzeitAbout ONWARD (GTX Medical)We are committed to developing innovative medical systems for individuals with spinal cord injuries. As a Software Quality Engineer at ONWARD, you will play a critical role in ensuring the production and delivery of high-quality medical systems.Key Job ResponsibilitiesDevelop Quality Strategy: Develop a quality strategy to ensure...
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Life Sciences Compliance Professional
vor 17 Stunden
Lausanne, Waadt, Schweiz Michael Page International (Switzerland) SA VollzeitMichael Page International (Switzerland) SA is seeking an experienced Regulatory Affairs Engineer to join their team.Key Responsibilities:Develop and maintain relationships with regulatory agencies.Collaborate with cross-functional teams to ensure regulatory compliance.Identify and implement process improvements.Provide technical support and guidance to team...
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Head of Pharmacovigilance and Medical Affairs
Vor 6 Tagen
Lausanne, Waadt, Schweiz Voisin Consulting SARL VollzeitSafety Lead Physician Job SummaryWe are seeking a highly skilled physician to lead our Safety Surveillance team and contribute to the development of our capabilities.This position offers an exciting opportunity to work on complex drug projects and drive innovation in safety surveillance and medical affairs.Key ResponsibilitiesDevelop and implement safety...
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Regulatory Project Manager
Vor 2 Tagen
Lausanne, Waadt, Schweiz Distalmotion SA VollzeitRequired Skills and QualificationsTo be successful in this role, you will need:Education and ExperienceBachelor's degree; advanced degree preferred.Minimum 5 years of regulatory affairs experience within the medical device industry in a global environment including Europe and USA.Skills and AbilitiesWorking knowledge of MDR including certification, technical...
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Regulatory Compliance Specialist
Vor 3 Tagen
Lausanne, Waadt, Schweiz Medtronic VollzeitWe are looking for a Regulatory Compliance Specialist to join our team in Tolochenaz, Switzerland. As a key member of our quality team, you will be responsible for ensuring the compliance of our processes and products with relevant regulations and standards.In this role, you will work closely with our manufacturing, engineering, and development teams to...
Regulatory Affairs Professional
vor 1 Woche
About MedTech Innovator
We strive to be at the forefront of medical innovation, harnessing cutting-edge technologies to redefine the boundaries of minimally invasive surgery.
Our team embodies a culture of inclusivity, diversity, and continuous growth, where talented professionals collaborate to drive progress and shape the future of medicine.
If you are driven by a passion for medical innovation and regulatory excellence, we invite you to join our mission to make on-demand robotic surgery a new standard in medicine.
Job Summary:
The Regulatory Affairs Specialist plays a critical role in driving the success of our regulatory initiatives. This position oversees substantial and complex regulatory projects, ensuring compliance with regulatory requirements, customer satisfaction, and patient well-being, while maintaining our internal QMS and global regulatory standards.
Main Responsibilities:
Support our products in global markets by drafting and coordinating regulatory documentation for submissions, notifications, renewals, establishment registrations, product listings, and letters to file.Lead cross-functional teams to achieve project objectives and milestones related to planned regulatory submissions, ensuring timely completion and quality results.Maintain CE Technical Documentation in accordance with EU Directive and Notified Body requirements.Stay abreast of and interpret all applicable regulatory and legal requirements, providing guidance to colleagues as needed.Apply standardized processes for product classification assessments and regulatory product change evaluations, including collaborating on the development of regional regulatory strategy and execution.Partner with relevant team leaders and subject matter experts to design, implement, and document required clinical and non-clinical tests.Guarantee alignment between the DHF and submission file with the expectations of the FDA, MDR, and other national or local regulatory requirements.Act as a subject matter expert to advise our QA team in implementing the QMS according to FDA and MDR standards.Seek support when necessary and collaborate with external consultants and third parties.Represent our company, products, and processes in communications and meetings with regulators (e.g., FDA, Notified Body).Serve as the point of contact for regulatory matters with external partners (distributor, legal agent, EC Rep, Importer).Other duties as assigned.Work Experience and Education Requirements:
Bachelor's degree; advanced degree preferred.Minimum 5 years of regulatory affairs experience within the medical device industry in a global environment, including Europe and USA.Key Skills and Qualifications:
A comprehensive understanding of FDA and MDR regulations, including experience with premarket notification (510(k)) and technical documentation.A working knowledge of FDA Quality System Regulation (21 CFR 820), EU MDR, ISO standards, and the ability to apply them in practice.Excellent communication and collaboration skills across all levels of the organization, with the ability to influence through constructive and collaborative means.A team-oriented individual with a flexible and creative approach.Scientific rigor, attention to detail, and analytical and synthesis skills.Demonstrated computer skills, strong written and interpersonal communication skills.Ability to thrive in a fast-paced, dynamic environment undergoing significant growth and change.Passionate about talent development, coaching, and mentorship.Experience in large-scale organization change efforts.Experience working within and across a matrixed organization.Benefits:
An opportunity to work in a fast-growing company active in one of the most promising fields of medicine.A permanent contract with 25 days of paid vacation.A dynamic atmosphere in an internationally minded environment.The benefit of one day per week working remotely to boost flexibility.Other benefits: Mobility plan, competitive company pension plan, support for gym memberships.Regular team-building events such as boot camps, skiing, and much more.