Regulatory Affairs Coordinator

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 Coordinator

The Regulatory Affairs Coordinator is responsible for supporting the Regulatory Affairs department and assigned projects. As a member of the Regulatory organization, this position works collaboratively with management and staff to maintain Regulatory Affairs internal processes and provide Regulatory Affairs deliverables in support of Distalmotion’s products and systems.

Tasks:

• Support and organize regulatory documentation for submissions, change notifications, and periodic reports (PSUR, PMS, annual reports, etc.) including maintaining reporting schedules.
• Maintain required renewals, establishment registrations, product listings, small business applications, EUDAMED, and other regulatory commitments.
• Participate in the preparation and publishing of regulatory filings (e.g. technical files, 510(k), IDE, etc.) and responses including document compilation.
• Review documents and submissions for completeness and submit to local authorities as directed.
• Support maintenance of Technical Documentation per EU Regulation and Notified Body requirements.
• Provide administrative support for regulatory department (e.g. purchase orders, invoicing, communication logs, databases, audit support, translation of documentation projects etc.) and assist with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Maintain regulatory archives for all documentation and registrations.
• Conducts searches of existing files for requested information.
• Research and monitor regulatory guidance, standards, and emerging regulatory topics.
• Performs other activities as assigned and/or instructed by direct manager or regulatory staff.

Work Experience and Education requirements:

• Bachelor's degree in engineering or related science.
• Minimum 2 years of regulatory affairs experience within the medical device industry.

Knowledge, Skills & Abilities required:

• Excellent English communication skills (written and verbal).
• Familiarity with FDA and MDR regulations and regulatory submissions.
• Team player with attention to details.
• Demonstrated computer skills including MS Word and Adobe Acrobat.

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.

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.