Post Market Surveillance Leader

About us

At Distalmotion, we aim to deliver the benefits of robotic surgery to more surgeons, more hospitals, and more patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive surgery.

We are a diverse, international team, headquartered in Lausanne, Switzerland, with a growing presence and footprint globally. With over 150 members, more than 25 nationalities, speaking over 15 languages, we are all united by the same goal — bringing patients the best in minimally invasive surgical care.

Are you looking for a new fulfilling challenge in a fast-growing medical device company? Join a team engaged in empowering robotic surgery, the new medical revolution.

About Post Market Surveillance Leader:

We are looking for a Post Market Surveillance (PMS) Leader to manage and execute all aspects of post-market surveillance for our surgical robotic systems and associated accessories in both the European and U.S. markets. In this role, you will take ownership of the PMS process, from data collection and analysis to regulatory reporting and implementing corrective actions. You will directly implement post-market activities, ensuring compliance with applicable regulations and proactively addressing product safety and performance concerns.

As a key member of the regulatory affairs team, you will collaborate with cross-functional teams but will also be responsible for executing tasks independently, including preparing and submitting reports, analyzing real-world data, and driving corrective and preventive actions based on your findings.

Duties and Responsibilities:

Post Market Surveillance Program Management:

• Develop, implement, and manage the post-market surveillance strategy and processes for our medical devices, ensuring compliance with EU MDR, FDA regulations, and ISO 13485.
• Take direct ownership of PMS activities, including collecting and analyzing product performance data, managing adverse event reports, and conducting trend analysis.
• Proactively monitor the safety, effectiveness, and performance of devices post-launch, identifying potential issues early and implementing corrective actions as needed.

Regulatory Reporting and Compliance:

• Prepare, review, and submit regulatory reports, including De Novo Annual Reports, Periodic Safety Update Reports (PSURs), Vigilance, Field Safety Corrective Actions (FSCA), and Medical Device Reports (eMDRs), ensuring timely and accurate submissions to the relevant authorities.
• Monitor and manage vigilance and trend reporting and compliance with post-market surveillance requirements in both the EU and U.S. regulatory environments.

Data Analysis and Product Monitoring:

• Lead the collection and analysis of post-market data (e.g., product complaints, clinical outcomes, adverse events) to identify safety signals, product performance issues, and trends.
• Provide inputs and analysis to management review and other internal initiatives.
• Conduct hands-on data analysis and report findings to stakeholders, highlighting areas for improvement and recommending corrective actions.
• Execute risk assessments and ensure data consistency with risk management files in compliance with ISO 14971.

Corrective and Preventive Actions (CAPA):

• Take direct responsibility for initiating, managing, and driving CAPA activities related to post-market surveillance findings.
• Perform root cause analysis of identified issues, determine appropriate actions, and track the implementation of solutions to ensure the safety and quality of our products.

Cross-Functional Collaboration:

• Collaborate closely with internal teams such as Regulatory Affairs, Quality Assurance, R&D, Clinical Affairs, Manufacturing, and Customer Experience to ensure post-market issues are addressed efficiently.
• Provide clear, actionable insights to senior management and other departments to drive continuous product improvement and ensure ongoing compliance.

Continuous Improvement:

• Actively seek opportunities for process improvements in the PMS activities, suggesting innovative ways to streamline data collection, reporting, and analysis.
• Ensure continuous monitoring of product performance to identify and address potential issues before they affect patient safety or regulatory compliance.

Training and Education:

• Provide hands-on training to internal teams on PMS processes, regulatory reporting requirements, and best practices.

• Stay up-to-date on the latest regulatory changes and industry best practices in post-market surveillance and medical device safety.

Work Experience and Education requirements:

• Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences, Biomedical Sciences, Regulatory Affairs). A Master’s degree or other advanced qualifications are a plus.
• At least 5 years of hands-on experience in post-market surveillance, regulatory affairs, or quality assurance in the medical device industry, with a strong focus on execution.
• Proven experience working directly with product performance data, vigilance reporting, risk management, regulatory compliance, and clinical studies/data.
• A solid background in working with complex medical devices (preferably surgical robots or related technologies) is highly desirable.

Knowledge, Skills & Abilities required:

• Strong knowledge of medical device regulations, including MDR (EU), FDA 21 CFR, and ISO 13485.
• Deep understanding of risk management processes (ISO 14971) and post-market surveillance best practices.
• Proficient in data analysis and the use of tools/software for monitoring and reporting (e.g., Excel, complaint management systems).
• Strong written and verbal communication skills with the ability to communicate complex findings to both technical and non-technical stakeholders.
• Self-starter with the ability to execute tasks independently and efficiently in a fast-paced, dynamic environment.
• Proficiency in English is required. Additional language skills (e.g., German, French) are a plus.

Benefits:

• Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.

• A dynamic atmosphere in an internationally minded environment.
• Permanent contract with 25 days of paid vacation.
• Benefit from one day to two days per week working remotely to boost flexibility.
• Attractive talent development programs and initiatives empowering employees to enhance their skills and fostering professional development growth.
• Mobility plan, competitive company pension plan, support for gym memberships.
• Regular team building events such as boot camps, skiing and much more.

Distalmotion is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all qualified applicants and employees.

Distalmotion is a medical device company founded and headquartered 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). We are all united by the same goal - to empower more surgeons and hospitals to deliver the benefits of robotic surgery to more patients. We can only do this with the right people in our team. Apply now and be part of the mission to bring patients the best in minimally invasive care.

For further information visit: distalmotion.com and follow us on LinkedIn/Twitter: @Distalmotion.