Jobs in Puidoux, vd

Join Us in Empowering Access to Robotic Surgery

At 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 hospital outpatient departments (HOPDs), ambulatory surgical centers (ASCs), or traditional operating rooms, we are enabling more healthcare providers to deliver high-quality care by offering surgeons the choice to provide the best treatments to their patients.

We are a global MedTech company driven by Excellence, Thinking Big, a Can-Do mindset, Care, and Trust. These values guide our work as we develop solutions that remove barriers to robotic surgery access.

If you’re passionate about improving healthcare and want to be part of a highly innovative and exciting journey, join us in bringing novel solutions to market and expanding access to robotic surgery.

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.

Duties and Responsibilities :

• Collaborate with cross-functional Distalmotion’s teams (R&D, Quality, Clinical, Marketing, etc.) to develop and implement regulatory strategies that meet the requirements of European and international markets.
• Lead regulatory project timelines, track progress, and ensure milestones are met in a timely manner. Coordinate with various departments to ensure regulatory timelines align with product development and commercialization goals.
• Assess and evaluate changes to existing products, processes, or manufacturing systems to determine their impact on regulatory compliance. Work with internal Distalmotion’s teams to ensure appropriate regulatory pathways are followed for changes such as design modifications, process changes, or supplier changes. Document and manage regulatory impact assessments to ensure any necessary filings (e.g., 510(k) submissions, Technical File updates) are completed.
• Support Distalmotion products in global markets and author and organize regulatory documentation for submissions, notifications, renewals, establishment registrations, product listings, and letters to file.
• Maintain CE Technical Documentation as per EU Regulation and Notified Body requirements.
• Identify and understand all applicable regulatory and legal requirements.
• 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 :

Knowledge, Skills & Abilities required :

Benefits :

Distalmotion is a medical device company founded and based in Lausanne, Switzerland. It was founded in 2012, as a spin-off from the Robotics Lab of the Swiss Federal Institute of Technology in Lausanne (EPFL).Our objective is to remove the complexity out of robotic surgery in order to fast track its widespread adoption in minimally invasive care. To do so, we want to continue disrupting minimal invasive surgery - but we will only succeed with the right people on our team. Join our team to address critical healthcare needs and improve patients’ lives !

For further information visit : dexter.surgery and follow us on LinkedIn / Twitter : @Distalmotion.