Regulatory 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.

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 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. Responsibilities include:

• Implement Product Registration (Regulatory Affairs) processes within the company’s electronic Quality Management System at the Breas US site and maintain their compliance with MDSAP, QSR and ISO 13485, as well as their effectiveness, including analysis and implementation of new and changed regulatory requirements.
• Perform and maintain product regulatory submissions (e.g. CE-marking, US 510(k)) and product registration for the installed base and products designed and/or manufactured by Breas Medical.
• Monitor expiration and ensure timely renewal of regulatory listings and licenses.
• Monitor inquires from regulatory authorities and notified bodies, and coordinate and prepare responses with input from subject matter experts.
• Perform training in regulatory affairs processes and promote the awareness of regulatory requirements.
• Monitor regulatory compliance of the Quality Management System and report the status of regulatory activities to management on monthly and quarterly basis, as well as forwarding information about other significant compliance issues or regulatory changes upon becoming aware;
• Perform regulatory reporting with regulatory authorities and notified bodies in applicable countries;
• Monitor and analyze new and changed regulatory requirements.
• Conduct regulatory assessment of new products and design changes, and prepare evaluations, letters-to-file and other regulatory documentation as required.
• Support external audits and inspections.

Requirements:

• BS degree and/or Master's degree.  
• Regulatory Affairs (RAPS) certification a plus
• At least 5 years of Regulatory Affairs experience within medical devices
• Demonstrated understanding of laws, regulations, standards, and guidance related to medical device products
• Experience working with regulatory submissions to FDA and/or Health Canada. 510(k) experience is a plus.