Are you a senior expert in medical device regulatory affairs? Would you like to use your knowledge to support innovative companies in setting up strategies and navigate the regulatory landscape? If you also want to work in a team-oriented and supportive environment together with other senior experts, this may be your next job! About us … Continue reading We are looking for a Senior Regulatory Consultant, Medical Device
RegSmart Life Science has signed an agreement with Aleap, the incubator hub for health startups in Oslo, Norway. The purpose is to support the innovative early-stage community companies with regulatory advice when developing pharma and medical device products. ”We are excited to partner with Aleap and support their member companies to navigate the complex regulatory … Continue reading RegSmart new partner at Aleap, the health startup incubator hub in Oslo
Another year has passed. And what a year! We have settled in just fine in our new offices at Eklundshovsvägen 5, strengthened our senior consultancy team and added new services to our portfolio. Let us summarize the highlights. A strengthened RegSmart team We have welcomed experts in project management, regulatory drug development and medical device … Continue reading RegSmart year summary 2022
During September 2022, RegSmart starts a collaboration with Matthias Rother and Rolf Karlsten as sub-consultants to RegSmart aiming at offering clinical development plans within pharma and medical device. “The clinical and regulatory plans are closely integrated, and central parts of the overall development plan” explains Marie Gårdmark, CEO at RegSmart. “We have seen that small … Continue reading RegSmart adds clinical development plans as service
Welcome Anders Juréus! On April 19 you joined our team as senior consultant drug development. What is your background, prior to joining RegSmart? I have extensive and broad drug development experiences from the pharmaceutical industry as well as academia and regulatory authorities. Most recently, I come from the Swedish Medical Products Agency were I held … Continue reading Welcome to RegSmart, Anders Juréus, senior consultant drug development
The first episode of the podcast Idé till patient (Idea to patient) will be released on April 12. The podcast series is a co-production between the companies within the CTR-group and SwedenBIO. The series comprises six episodes where invited guests from the pharma industry will be discussing the pitfalls and highlights in early drug development. … Continue reading CTR launches podcast together with SwedenBIO
Earlier this year, Center for Translational Research (CTR) revealed the establishment of a new regulatory company, RegFile AB, complementing RegSmart in its services. RegFile, led by CEO Maria Santesson, is now ready to start providing regulatory affairs support to customers. Maria Santesson is one of the founders of RegFile and will start as the new … Continue reading RegFile is now in operation
Welcome Anna Wannberg! On March 28 you joined our team as senior consultant in medical devices. What is your background, prior to joining RegSmart? Well, I have a long regulatory background, for the last ten years at the Swedish Medical Products Agency, MPA. My main focus there was regulatory questions, such as borderline and classification, but also … Continue reading Welcome to RegSmart, Anna Wannberg, senior consultant medical devices
The mission is to support clients with regulatory affairs services in connection to, and beyond, their regulatory submissions for marketing approval. CEO will be Maria Santesson. “It is with great enthusiasm I take on the task of setting up operational regulatory consulting within CTR, and I look forward to working with all the dedicated experts … Continue reading CTR establishes regulatory company, complementing RegSmart
Welcome Karin Westermark! On February 1, you joined our team as senior consultant in medical devices. What is your background, prior to joining RegSmart? Most recently, I worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for six years – first as Assessor and the last three years as Senior Assessor … Continue reading Welcome to RegSmart, Karin Westermark, senior consultant medical devices
