Empowering Access to Robotic Surgery
At Distalmotion, 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.
We are enabling more healthcare providers to deliver high-quality care by offering surgeons the choice to provide the best treatments to their patients, whether in hospital outpatient departments, ambulatory surgical centers, or traditional operating rooms.
About Us
We are a global MedTech company driven by Excellence, Thinking Big, a Can-Do mindset, Care, and Trust. These values guide our work as we develop solutions that remove barriers to robotic surgery access.
About Regulatory Affairs Specialist:
The Regulatory Affairs Specialist is responsible for leading substantial and complex regulatory projects. 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.
Responsibilities
* Collaborate with cross-functional teams 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.
* Assess and evaluate changes to existing products, processes, or manufacturing systems to determine their impact on regulatory compliance.
* 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.
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 & 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 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.
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.
* 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.