Regulatory Affairs Specialist

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-pace, 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.

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.