Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to lead substantial and complex regulatory projects. As a key member of our Regulatory organization, this position will work closely with management to establish the overall strategic direction for Regulatory Affairs.
About the Role
* Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to develop and implement regulatory strategies that meet European and international market requirements.
* Lead regulatory project timelines, track progress, and ensure milestones are met in a timely manner. Coordinate with various departments to align regulatory timelines 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 teams to ensure appropriate regulatory pathways are followed for changes such as design modifications, process changes, or supplier changes.
* Maintain CE Technical Documentation as per EU Regulation and Notified Body requirements.
* Identify and understand all applicable regulatory and legal requirements.
* Partner with relevant team leaders and subject matter experts to plan, execute, and document required clinical and non-clinical tests.
* Ensure consistency of the DHF and submission file with FDA, MDR, and national/local regulatory requirements.
* Act as subject matter expert to advise QA team on making QMS compliant with FDA and MDR requirements.
* Seek support where applicable, interact, and manage external consultants and third parties.
* Represent Distalmotion's company, products, and processes in communications and meetings with regulators.
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.
Key Skills and Abilities
* Working knowledge of MDR, including certification, technical documentation, and change notifications.
* Working knowledge of FDA regulations, including experience with Pre-Submissions and Premarket notification (510(k)).
* Excellent communication 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 detail, and analytical and synthesis skills.
* Demonstrated computer skills, strong written and interpersonal communication skills.
About Distalmotion
Distalmotion is a medical device company founded and based in Lausanne, Switzerland. Our objective is to remove complexity from robotic surgery to fast-track its widespread adoption in minimally invasive care. We want to continue disrupting minimal invasive surgery by working with the right people on our team.