Do you know regulatory affairs CMC? Do you want to use your knowledge in the very front of pharmaceutical development? At RegSmart we support innovative companies with our regulatory expertise. As Senior Consultant, you will get to work with a variety of projects, with many different companies. At RegSmart, there are always colleagues ready for … Continue reading Join our team – as Senior CMC Consultant
In January 2023 you joined our team as senior consultant, 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 eight years, as Assessor and Inspector, responsible for in-depth investigations of market surveillance cases with focus on medical … Continue reading Welcome to RegSmart, Mats Artursson, senior consultant medical device
RegSmart Life Science and the business incubator Uppsala Innovation Centre (UIC) has signed a partner agreement starting February 1, 2023. RegSmart will support UIC start-up pharma and medical device companies with regulatory advice. RegSmart will also contribute to UIC’s special offerings to the Life Science community companies. Uppsala Innovation Centre (UIC) offer innovative startups and … Continue reading RegSmart new partner at Uppsala Innovation Centre (UIC)
Even before the EU regulation on medical devices (MDR) came into force, medical technology companies and doctors were concerned that it would endanger the availability of medical devices in the EU. Unfortunately, the fears have come true. Above all, notified bodies have a limited capacity following the stricter requirements since the MDR came into force. … Continue reading Unclear proposal from the EU Commission on how to solve the MDR challenges
Are you a senior expert in medical device regulatory affairs with experience of consulting as well as experience from leadership? Would you like to use your knowledge to support innovative companies in setting up strategies and navigate the regulatory landscape? Then this position at RegSmart could be something for you! About us RegSmart Life Science … Continue reading We are looking for a Director Regulatory, Medical Device
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
EMA has launched a new pilot to assess whether the analysis of ‘raw data’ by regulatory authorities improves the evaluation of marketing approval for new medicines. The pilot will run for 2 years starting in September. Still, regulatory decisions within EU are based on the assessment of applicant’s own analyses, which in turn must be thoroughly … Continue reading Potential step change – EU regulators get to play with data
