RegSmart Life Science is a rapidly growing regulatory consultancy firm in pharma and medical device that facilitate the development process for companies in the Life Sciences and help them navigate in a complex and evolving regulatory landscape.
Our motto is Regulatory Relevant & Scientifically Sound.
We are a great team of experts with extensive regulatory experience and firm scientific knowledge who use our collective experience in regulatory affairs to make a difference in every project. Take a look at our staff: https://regsmart.se/board/
The company is located in Uppsala and there are great possibilities to work either from a distance or at the office. RegSmart offers competitive terms and are flexible when it comes to starting date and working hours. With strong finances and high demand for our services, the future looks prosperous!
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!
As Senior Consultant at RegSmart we match your own competence with the needs of our clients & projects.
Here are some examples of possible responsibilities:
* Strategic support in setting up the regulatory strategy for new medical devices or drug-device combination products (EU and US).
* Support in definition and classification of products.
* Lead the compilation of regulatory files and prepare documentation for the application to notified bodies.
* Managing technical documentation and risk management.
* Responsible for organizing and coordinating projects independently.
* Participate in and/or arrange meetings with notified bodies and governmental authorities.
* Review risk-benefit work and define strategies to become compliant.
* Support clinical evaluations and preparations for clinical investigations.
The most important thing to succeed as a Senior Consultant is to be able to share your profound expertise in one or more of the areas that our clients need support within.
We do not expect you to know everything, but we want you to have extensive regulatory knowledge and/or experience in one or more of the following areas:
* Requirements for medical devices according to MDR/IVDR for CE marking in EU / FDA approval.
* Development of medical devices
* Drug-device combination products
* Digital health devices; medical device software and applications, including cyber security
* In vitro diagnostic medical devices regulations (IVDR)
* Clinical evaluation and investigation of medical devices
* Compilation and review of technical files to comply with regulations / ISO standards / guidelines
* Communication with notified bodies / FDA including compiling regulatory files
* Experience as inspector or reviewer from regulatory agency or notified body.
* Managing post market surveillance processes.
You also need an academic degree in science or engineering and a professional level of English.
To enjoy your work at RegSmart, we think that you are science-driven, good at expressing your opinions with the recipient in mind, as well as interested in finding effective solutions to our clients’ needs.
Does this sound interesting?
In this recruitment process, we collaborate with Clockwork Recruitment & Staffing. Submit your application at www.clockworkpeople.se no later than February 28. If you have questions please contact recruitment consultant Mattias Gäreskog on 0733-51 27 09 or via email: email@example.com