Senior Regulatory Consultant, Medical Devices

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!

RegSmart is a rapidly growing regulatory consultancy firm building on extensive regulatory experience and on firm scientific knowledge. Our aim is to facilitate the development process for companies in the Life Sciences.

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.

Qualification requirements:

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. 

About RegSmart:

We are a great team of experts who use our collective experience in regulatory affairs to make a difference in every project. Take a look at our staff:

We are located at Eklundshovsvägen 5 in Uppsala. There are great possibilities to work either from a distance or at the office.

We offer 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!

Don´t hesitate to contact us if you have any questions.

Agneta Larhed phone: +46 (0) 72-74 67 350