Regulatory Affairs Specialist

Join Us in Empowering Access to Robotic Surgery

At Distalmotion we believe patients deserve bestinclass minimally invasive care. Our mission is to empower access to the benefits of robotic surgery. The DEXTER Robotic Surgery System uniquely simplifies operations so more surgeons in more ORs can provide the benefits of robotics to more patients.

Whether in hospital outpatient departments (HOPDs) ambulatory surgical centers (ASCs) or traditional operating rooms we are enabling more healthcare providers to deliver highquality care by offering surgeons the choice to provide the best treatments to their patients.

We are a global MedTech company driven by Excellence Thinking Big a CanDo mindset Care and Trust. These values guide our work as we develop solutions that remove barriers to robotic surgery access.

If youre passionate about improving healthcare and want to be part of a highly innovative and exciting journey join us in bringing novel solutions to market and expanding access to robotic surgery.

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 Distalmotions products and services meet the needs of our patients customers regulators and remain compliant to our internal QMS and global regulations.

Duties and Responsibilities:

• Collaborate with crossfunctional Distalmotions teams (R&D Quality Clinical Marketing etc. to develop and implement regulatory strategies that meet the requirements of European and international markets.
• Lead regulatory project timelines track progress and ensure milestones are met in a timely manner. Coordinate with various departments to ensure regulatory timelines align 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 Distalmotions teams to ensure appropriate regulatory pathways are followed for changes such as design modifications process changes or supplier changes. Document and manage regulatory impact assessments to ensure any necessary filings (e.g. 510(k) submissions Technical File updates) are completed.
• Support Distalmotion products in global markets and author and organize regulatory documentation for submissions notifications renewals establishment registrations product listings and letters to file.
• Maintain CE Technical Documentation as per EU Regulation and Notified Body requirements.
• Identify and understand all applicable regulatory and legal requirements.
• Partner with all relevant Distalmotion team leaders and subject matter experts to plan execute and document all required clinical and nonclinical 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 Distalmotions 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:

• Bachelors 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 MDR including certification technical documentation and change notifications.
• Working knowledge of FDA regulations including experience with PreSubmissions and Premarket notification 510(k).
• 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 fastpace 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 fastgrowing 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.
• 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 a medical device company founded and based in Lausanne Switzerland. It was founded in 2012 as a spinoff 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.