Regulatory Affairs (RA) Specialist



When you can´t breathe, nothing else matters.

Our vision at Breas is to provide innovative solutions that enable people with chronic respiratory conditions to live life to the fullest.

We are looking for a Regulatory Affairs (RA) Specialist who wants to make an impact and change the world of ventilation for the better.

At Breas Medical, you will get the chance to work on projects of high importance that improve our end users quality of life. Working at Breas Medical will most likely be a new, impactful chapter of your life, and be a great opportunity for growth.

As one of our key talents, you will be joining Breas at a very exciting stage of our journey. We have just launched two new product series within our Vivo range, with a total of seven new ventilator products. These new products enable us in our strive to be our customers preferred choice and the global market leader within the mechanical ventilator product segment.

This exciting position is within our QA & RA department based at the Breas global headquarters in Mölnlycke, Sweden. Breas Medical is owned by Fosun Pharmaceutical (Group) Co., Ltd.

You will be responsible and lead

 As a RA Specialist, you will join Breas Medical's global QA&RA team with members in Sweden, UK, US and China. You will work closely with our RA Manager and colleagues from R&D, Product Management & Marketing and other functions, to plan and perform regulatory submissions, product registrations and renewals towards and in collaboration with the Notified Body, Regulatory Authorities and Distributors.

Your main focus is to ensure Breas Medical's regulatory compliance so products can be distributed on applicable markets, including EU (CE-marking to MDR), UK (UKCA-marking), US (FDA 510(k)), Japan (PMDA), China (NMPA), Australia (TGA) and over 40 other countries.

We are certified to MDSAP, ISO 13845 and MDD/MDR, and you will be part of the core team to prepare and host the annual audits, as well as unannounced audits. You will also coordinate and prepare responses to requests from Regulatory Authorities and distributors.

Maintain up-to-date knowledge and understanding of current regulatory requirements.

  • Work closely with Technical Product Manager/Risk Manager, Standards Compliance Engineer, Clinical Affairs Manager/Specialist and other subject matter experts, and document and communicate the conclusions of regulatory assessments and investigations.
  • Plan, conduct and report on regulatory submissions, and prepare responses to regulatory inquiries.
  • Prepare and maintain regulatory plans, classification assessments and technical files, and coordinate technical file assessments.
  • Represent RA towards Sales and Marketing & Product Management, and support with regulatory requirements and guidance as input to product lifecycle.
  • Monitor status and progress of ongoing technical file/regulatory submission nonconformities, and escalate lack of progress.
  • Monitor expiration of product registrations and initiate action for renewal.
  • Act as RA representative for assigned projects and processes, and provide regulatory advice and guidance to colleagues when requested.

Experience you will bring

  • You are organized and can work independently, and keep track of and coordinate many concurrent
  • You have a hands-on, can-do attitude that will fits well with our informal, entrepreneurial and friendly culture. You get things done and learn quickly.
  • You appreciate thorough, well structured documentation and are good at reviewing, compiling and organizing documentation.
  • You enjoy working together with colleagues to get products on the market.
  • Formal qualifications include an academic degree in regulatory affairs, science, medical, engineering or other relevant field plus at least 3 years' relevant experience from organizing, preparing and reviewing structured, regulated documentation.
  • Education and/or experience within Regulatory Affairs for medical devices is a strong plus.


More About Us

About Breas

Our focus is first and foremost on the patients and customers we serve. Breas Medical was founded in 1991 in Gothenburg, Sweden, and has become one of the global leaders in Home Mechanical Ventilation, Airway Clearance and Sleep therapy. Our vision is to provide better breathing and quality of life to respiratory patients around the world and to help patients transition from Hospital to Home.

Breas is headquartered in Sweden and has subsidiaries in the UK, Germany, Spain, USA and China. Breas has approximately 250 employees. Together with a network of highly specialized distributors, we serve over 40 countries worldwide. The Breas brands Vivo, Nippy, Clearway and Z1 are widely recognized and appreciated for their performance, design and ease of use.

We highly value our relationships, never compromise on quality, continuously improve customer support and expand our clinical excellence program that consists of study days, webinars, educational videos, symposia and clinical research. We work closely together with key opinion leaders around the world to stay updated on the latest clinical insights. All Breas products are designed to fulfil our vision and to help patients transition from Hospital to Home.  We strive to become a total solution provider offering a broad range of products, from smart CPAPs to Bi-levels, NIV ventilators, Life-Support ventilators and Airway Clearance devices. Add to that a growing range of accessories and remote connectivity solutions.

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