Jobbeschreibung
LARALAB's goal is to revolutionize the planning of cardiac interventions and improve the lives of patients worldwide. We are developing cloud-based planning software powered by deep learning technology to support the innovation of new minimally invasive cardiac procedures, and to make these procedures available to patients in need. We have collaborations with leading clinics and medical companies, and are backed by strong investors.
Would you like to play a central role in our story? We are looking for a Quality & Regulatory Affairs Manager to join our team. In this key position, you will develop and implement regulatory strategies to support our business and product objectives. You will take responsibility for our regulatory submissions (in multiple regions) to ensure that our continuously improving products and innovations benefit patients. You will be responsible for our ISO 13485 certified quality management system and drive continuous process and quality improvements. Join us and make a difference!
- Develop and implement regulatory strategies for our products and expanding markets
- Manage regulatory submissions (in multiple regions incl. US) and interact with notified body and regulatory autorities (e.g. FDA)
- Own our MDR and ISO 13485 certified Quality Management System and continously drive improvements to ensure high quality of our products and services
- Prioritize and manage projects and tasks of the QM/RA team (+ Opportunity to also take over responsibility for personnel)
- Work hands on regulatory topics (e.g. technical file) and quality topics (e.g. CAPA)
- Passion for regulatory topics and driving the development of high-quality medical products
- A degree in science, engineering or similar
- At least 3 years of full-time professional experience working with medical device software (SaMD) in the regulatory affairs and/or quality management field
- Profound knowledge of regulations, laws, standards and guidance documents (e.g. MDCG) for clearing medical devices and quality processes for medical device manufacturers (e.g. MDR; 21 CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971)
- Experience with preparing the technical file for regulatory submissions and managing the review/acceptance process with notified bodies or authorities. Experience with FDA is a plus
- Experience in managing / taking responsibility in internal and external quality audits, e.g. by notified bodies or authorities
- High level of self-motivation, flexible mindset, ability to adapt in a fast-paced environment and proactive in finding solutions
- Applying your skills to improve peopes' lives instead of just optimizing the revenue of some big corporation
- The chance to be part of a growing international company and a passionate and highly skilled team
- Flexible working hours and remote working possibilities
- Fair compensation (incl. virtual share options)
- Company sports program (Wellpass + JobRad) and free snacks and drinks
- Many opportunities for personal growth
- An office centrally located in Munich