Regulatory Affairs Specialist
Vor 3 Tagen
About us
At 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 from robotic best-in-class technology.
Distalmotion has been created in 2012 by passionate and open-minded people with various experiences. Today, we are still convinced that an inclusive and international company culture is the best way to continue growing. Our leadership is highly committed to promote diversity among the teams and welcome every employee based on their identity.
You are looking for a new fulfilling challenge in a fast-growing medical device company? Join a team engaged in making on-demand robotic surgery the new medical revolution.
About Regulatory Affairs Specialist:
The Regulatory Affairs Specialist is responsible for leading substantial and complex regulatory projects.
As a member of the Regulatory organization, this position works with management to establish the overall strategic direction for Regulatory Affairs and works collaboratively across multiple internal departments as well as external regulatory and governing bodies to ensure Distalmotion's products and services meet the needs of our patients, customers, regulators, and remain compliant to our internal QMS and global regulations.
Tasks:
- Support Distalmotion products in global markets and author and organize regulatory documentation for submissions, notifications, renewals, establishment registrations, product listings, and letters to file.
- Plan and coordinate activities with cross functional partners and projects related to planned regulatory submissions to ensure achievement of project objectives and milestones.
- Maintain CE Technical Documentation as per EU Directive and Notified Body requirements.
- Identify and understand all applicable regulatory and legal requirements.
- Follow standardized processes for product classification assessments and regulatory product change evaluation including assisting in the development of regional regulatory strategy and execution.
- Partner with all relevant Distalmotion team leaders and subject matter experts to plan, execute and document all required clinical and non-clinical tests.
- Ensure consistency of the DHF and the submission file with the expectations of the FDA, MDR, and other national or local regulatory requirements.
- Act as subject matter expert to advise Distalmotion QA team in making the QMS compliant with FDA and MDR requirements.
- Seek support, where applicable, and interact and manage external consultants and third parties.
- Represent Distalmotion's company, products, and processes in communications and meetings with regulators (e.g. FDA, Notified Body).
- Be 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.
Knowledge, Skills & Abilities required:
- Working knowledge of FDA and MDR regulations including experience with premarket notification (510(k)) and technical documentation.
- Working knowledge of FDA Quality System Regulation (21 CFR 820), EU MDR, ISO standards and the ability to apply them in practice.
- Excellent communications skills across all levels of the organization with the ability to influence through constructive and collaborative means.
- Team player with a flexible and creative approach.
- Scientific rigor, attention to details and analytical and synthesis skills.
- Demonstrated computer skills, strong written and interpersonal communication skills.
- Ability to excel 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:
- Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.
- Permanent contract with 25 days of paid vacation.
- A dynamic atmosphere in an internationally minded environment.
- Benefit from 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.
-
Regulatory Affairs Specialist
Vor 7 Tagen
Lausanne, Waadt, Schweiz Intuitive Surgical VollzeitJob DescriptionWe are seeking a skilled Regulatory Affairs Specialist to join our team at Intuitive Surgical. As part of a 9-month project and the launch of a product in the biotechnology market, we require a candidate available immediately (within 1 month maximum). There are possibilities to continue on a permanent contract.Your Key Responsibilities:Prepare...
-
Regulatory Affairs Professional
Vor 3 Tagen
Lausanne, Waadt, Schweiz MedTech Innovator VollzeitAbout MedTech InnovatorWe 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...
-
Device Regulatory Affairs Manager
Vor 3 Tagen
Lausanne, Waadt, Schweiz MedTech Innovator VollzeitAbout MedTech InnovatorWe empower talented professionals to push the boundaries of medical innovation, leveraging cutting-edge technologies to transform the field of minimally invasive surgery.Our company culture fosters a spirit of collaboration, inclusivity, and continuous growth, where professionals from diverse backgrounds come together to drive progress...
-
Global Regulatory Compliance Specialist
Vor 3 Tagen
Lausanne, Waadt, Schweiz MedTech Innovator VollzeitAbout MedTech InnovatorWe are dedicated to pushing the boundaries of medical innovation, combining cutting-edge technologies to transform the field of minimally invasive surgery.Our company culture values diversity, inclusivity, and continuous growth, where talented professionals collaborate to drive progress and shape the future of medicine.If you are...
-
Document Control Specialist
Vor 7 Tagen
Lausanne, Waadt, Schweiz Intuitive Surgical VollzeitRole and ResponsibilitiesThe role involves working closely with cross-functional teams to ensure that regulatory requirements are met for the launch of a product in the biotechnology market. The position is available immediately (within 1 month maximum) and there are possibilities to continue on a permanent contract.Key Responsibilities:Prepare and compile...
-
Medical Device Regulatory Strategist
Vor 3 Tagen
Lausanne, Waadt, Schweiz MedTech Innovator VollzeitAbout MedTech InnovatorWe are a pioneering medical device company that leverages cutting-edge technology to revolutionize the surgical experience. Our team of innovators and experts shares a common vision: to make on-demand robotic surgery a new standard in medicine.We take pride in fostering an inclusive, diverse, and dynamic work environment where talented...
-
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...
-
Product Compliance Manager
Vor 7 Tagen
Lausanne, Waadt, Schweiz Intuitive Surgical VollzeitAbout the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist. You will play a key role in ensuring the success of our product launch in the biotechnology market. The position requires a high level of expertise in regulatory affairs and excellent communication skills.Your Key Responsibilities:Prepare and compile regulatory...
-
Compliance and Governance Expert
Vor 7 Tagen
Lausanne, Waadt, Schweiz Intuitive Surgical VollzeitCompany OverviewWe are a global leader in biotechnology based between Geneva and Lausanne. We aim to revolutionize healthcare through innovative technologies.Job SummaryWe are looking for a highly skilled Regulatory Affairs Specialist to join our team. As part of a 9-month project and the launch of a product in the biotechnology market, we require a...
-
Biotechnology Regulatory Specialist
Vor 4 Tagen
Lausanne, Waadt, Schweiz Consultys Suisse VollzeitWe are recruiting a Senior QA Specialist to join our teams in the French-Speaking part of Switzerland as part of our development at Consultys Suisse.Much more than concepts, our 3 values 'Respect, Recognition and Transparency' guide us and are the foundation of our history, the heart of our group's success.Key Responsibilities:Verify that production of...
-
Biosample Operations Specialist
Vor 5 Tagen
Lausanne, Waadt, Schweiz Debiopharm VollzeitWe are seeking a highly skilled Biosample Operations Specialist to join our team at Debiopharm.In this role, you will be responsible for the end-to-end management of biological samples in clinical trials, from feasibility to long-term storage.You will work closely with cross-functional teams to optimize biosample workflows and ensure compliance with ethical,...
-
Public Relations Specialist
Vor 6 Tagen
Lausanne, Waadt, Schweiz KFC Corporation VollzeitWe are looking for a Public Relations Specialist to help us manage our communications in a large multinational organization. As a key member of our Corporate Affairs team, you will be responsible for building relationships with internal stakeholders, franchisees, and providing counsel and advice rather than delivering activations in markets.This is a...
-
Quality Assurance Specialist
Vor 4 Tagen
Lausanne, Waadt, Schweiz Randstad VollzeitJob Title: Quality Assurance SpecialistCompany Overview:Randstad is a leading provider of quality assurance services, supporting laboratories in achieving excellence.Salary:The salary for this position is competitive and based on industry standards.Job Description:As a Quality Assurance Specialist, you will play a vital role in ensuring the highest standards...
-
Senior QA Specialist
vor 1 Tag
Lausanne, Waadt, Schweiz Panda International VollzeitPanda International is a leading company in the MedTech industry, dedicated to developing innovative products that meet the highest standards of safety, quality, and regulatory compliance. We are seeking a Senior QA Specialist on a freelance contract to support our growing team and ensure product quality and regulatory adherence.ResponsibilitiesThe...
-
Strategic Safety Guidance Position
vor 1 Tag
Lausanne, Waadt, Schweiz Voisin Consulting SARL VollzeitPharmacovigilance and Medical Affairs PositionWe 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...
-
Clinical Development Specialist
Vor 7 Tagen
Lausanne, Waadt, Schweiz Randstad Switzerland Vollzeit**Key Accountabilities:**We are seeking a highly skilled Clinical Development Specialist to join our team at Randstad Switzerland. As a Medical Science Liaison, you will be responsible for developing and maintaining strong peer-to-peer relationships with healthcare professionals.Your Key Responsibilities:Develop and maintain strong peer-to-peer relationships...
-
Safety Lead Physician Role
vor 1 Tag
Lausanne, Waadt, Schweiz Voisin Consulting SARL VollzeitAbout This RoleThe successful candidate will be a highly skilled physician with expertise in pharmacovigilance and medical affairs.This position offers an exciting opportunity to lead our Safety Surveillance team and contribute to the development of our capabilities.Key ResponsibilitiesDevelop and implement safety strategies that align with company...
-
Clinical Data Specialist
Vor 6 Tagen
Lausanne, Waadt, Schweiz Nestlé SA VollzeitAbout the RoleWe are seeking an experienced Clinical Data Specialist to join our team and contribute to the successful delivery of clinical trials. As a key member of our data management team, you will be responsible for implementing trial data management processes and ensuring adherence to current guidelines and internal processes.Key ResponsibilitiesManage...
-
Lausanne, Waadt, Schweiz headcount | recruitment driven by scientists VollzeitMedical Director Neurology Development Specialist (BH-2099-2)Sector: PharmaceuticalsThis role focuses on developing next-generation therapies for Alzheimer's, Parkinson's, and related disorders. Using cutting-edge technologies, we redefine precision medicine, biomarker innovation, and early-stage drug development.We're searching for a Clinical Lead...
-
IT and Infrastructure Solutions Specialist
Vor 5 Tagen
Lausanne, Waadt, Schweiz Debiopharm VollzeitJob Title: IT and Infrastructure Solutions SpecialistThis role requires a highly skilled individual with expertise in maintaining and optimizing IT infrastructure.We are seeking an IT and Infrastructure Solutions Specialist to join our team at Debiopharm, a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious...
