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.
DISTALMOTION WAS 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.
You are looking for a new fulfilling challenge in a fast-growing medical device company?
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 collaborates across multiple internal departments as well as external regulatory and governing bodies to ensure Distalmotion's products meet customer needs while remaining compliant to our QMS and global regulations.
Key Responsibilities:
* Supports Distalmotion products globally and creates regulatory documentation for submissions, notifications, renewals, establishment registrations, product listings, and letters to file.
* Plans and coordinates activities with cross-functional partners and projects related to planned regulatory submissions to achieve project objectives and milestones.
* Maintains CE Technical Documentation as per EU Directive and Notified Body requirements.
* Identifies and understands all applicable regulatory and legal requirements.
* Follows standardized processes for product classification assessments and regulatory product change evaluation, including assisting in regional regulatory strategy development and execution.
* Panthers with relevant team leaders and subject matter experts to plan, execute, and document required clinical and non-clinical tests.
* Ensures consistency of the DHF and submission files with FDA, MDR, and other national or local regulatory expectations.
* Acts as subject matter expert advising QA teams on QMS compliance with FDA and MDR requirements.
* Seeks support when necessary and interacts with external consultants and third parties.
* Represents Distalmotion's company, products, and processes in communications and meetings with regulators (e.g. FDA, Notified Body).
* Serves as point of contact for regulatory matters with external partners (distributor, legal agent, EC Rep, Importer).
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.
Skills and Abilities:
* Working knowledge of FDA and MDR regulations, including 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 collaboration.
* Team player with 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 fast-paced, dynamic environments undergoing significant growth and change.
* Passionate about talent development, coaching, and mentorship.
* Experience in large-scale organization change efforts.
* Experience working within and across matrixed organizations.
Benefits:
* Opportunity to work in fast-growing companies active in promising medical fields.
* Permanent contract with paid vacation.
* A dynamic atmosphere in internationally-minded environments.
* Flexibility with one day per week working remotely.
* Other benefits: mobility plan, competitive pension plan, gym membership support.
* Regular team building events such as boot camps, skiing, and 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 complexity out of robotic surgery for its widespread adoption in minimally invasive care.