Clinical Affairs Specialist
When you can´t breathe, nothing else matters. That’s why a career at Breas Medical matters.
Our mission is to improve the quality of life and care of respiratory patients around the world through a personal commitment to innovation, quality, and customer focus.
Are you passionate about clinical affairs and regulatory compliance?
Breas is seeking a dedicated Clinical Affairs Specialist (CAS) to join our team and enhance our capacity in this critical area. In this role, you will be responsible for executing clinical-regulatory requirements, with a primary focus on updating and preparing documentation on Clinical Evaluation, Post Market Surveillance, and Post Market Clinical Follow-Up in accordance with EU, UK, and Canadian regulations.
As a CAS, you will initiate and perform clinical activities such as customer surveys to generate necessary data. You will also structure data for presentations, conduct systematic literature reviews, and retrieve vigilance information using both internal and external sources/databases as needed. Additionally, you will perform periodic updates of the Breas State of the Art reports.
We are looking for a solution-driven individual who is comfortable in working independently and managing tasks within set timelines. If you have a keen eye for detail and a passion for clinical affairs, we would love to hear from you!
Main responsibilities:
- Conduct and update clinical evaluations and state of the art reports, including systematic information searches to retrieve data from the latest scientific publications, clinical guidelines as well as incident data from regulatory websites and databases.
- Compile and present data from clinical investigations, structuring it into tables and graphs for analysis.
- Prepare and maintain documentation for Post Market Surveillance (PMS) and Post Market Clinical Follow-Up (PMCF).
- Manage PMS/PMCF activities and compile data for clinical evaluation, post-market surveillance and risk management.
- Assess design changes to marketed products for safety/performance impact, evaluate the need for generating additional clinical data, and update clinical evaluation and PMS documentation accordingly.
- Stay current with global regulations on Clinical Evaluations, PMS, and PMCF, with focus on EU, UK, and Canadian markets.
- Work cross-functional and collaborate with other departments to collect and organize documentation materials.
To be successful in this job, we believe that you possess the following requirements and skills:
- PhD or Master’s degree in relevant field.
- At least 5 years experience from clinical/medical affairs positions within the Medtech industry.
- Previous experience in writing clinical evaluation plans and reports for minimum Class II devices as well as PMCF plans and reports and PSUR that have passed NB technical and clinical review.
- Good understanding of Design Control in accordance with ISO 13485 and risk management in accordance with ISO 14971 and the implications on clinical evaluation and PMS requirements.
- A thorough understanding of the different medical device regulations in MDSAP countries.
Be Part of a Mission That Makes a Difference
At Breas, you’ll be part of a dedicated global team with deep expertise in ventilation, airway clearance, and sleep solutions. We work across borders and disciplines to develop products that make a real difference in the lives of patients. Here, your work will directly support innovation and patient safety in a company where quality and compassion go hand in hand.
To apply, please submit your resume, and any other relevant materials. We look forward to hearing from you.
Please note that we work with continuous recruitment.
More About Us
Breas Medical is a global company headquartered in Sweden, with over 30 years of expertise in ventilation, airway clearance and sleep solutions. We are passionate experts dedicated to respiratory care, with unwavering focus on the patient and the caregiver, delivering high quality and reliable products. We respond to your changing needs with agility, and while growing globally, we take customer care personally. Our solutions cover a broad range of devices, consumables, service solutions, educational & training programs, and comprehensive connectivity capabilities to improve the quality of life of patients, from hospital to home.
Breas Medical employs over 300 people globally. Our solutions reach 50 counties around the world, and we manufacture our product in four countries, China, UK, Sweden, and the US.
Find out more about Breas:
educationbybreas.com
breas.com
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