If you want to make a difference in the quality of life of respiratory patients, you are welcome to join Breas Medical as a Clinical Affairs Manager reporting to the Head of Marketing & Product Management in Sweden. For the person with the right competence, the location of this role can be discussed (within Europe).
Clinical Affairs Manager
The regulatory environment regarding clinical evidence for medical devices is changing and becoming more demanding through the (new) regulations of MEDDEV 2.7.1 Rev 4 and MDR. Therefore, Breas installs the position of Clinical Affairs Manager.
This position aims to determine Breas clinical affairs strategies and actions to implement and execute clinical-regulatory requirements defined by various regulations. The main focus will be on creating effective processes and adequate documentation in line with MEDDEV 2.7.1 Rev 4, MDR, US and other regulations, concerning Clinical Evaluations, Post Market Surveillance and Post Market Clinical Follow-Up. The Clinical Affairs Manager will ensure that procedures and documentation fulfill standards and will initiate clinical activities when necessary to generate required data.
To achieve the above, the Clinical Affairs Manager has a thorough understanding of the regulations, keeps him/herself updated on any changes and is able to translate the requirements into concrete actions for the company. The Clinical Affairs Manager will closely work together with other functions in the company, e.g. RA, Product Applications Manager, Risk Management, R&D, Product Management and others.
The Clinical Affairs Manager will integrate Clinical Affairs tasks with a.o. the design controls process to ensure that we can bring new products to the market in a timely and compliant manner. The Clinical Affairs Manager is part of the clinical and product management team and will report to the VP Marketing & Product Management.
Essential Job Functions
• Maintain up-to-date knowledge of regulations regarding MEDDEV 2.7.1 Rev 4 and MDR as well as US and other global regulations concerning Clinical Evaluations, Post Market Surveillance and Post Market Clinical Follow-Up.
• Prepare and maintain effective processes for Clinical Evaluations, Post Market Surveillance and Post Market Clinical Follow-Up.
• Prepare Clinical Evaluation Plans and Clinical Evaluation reports for Breas products
• Organize Post Market Surveillance activities and PMS reports
• Organize Post Market Clinical Follow-Up activities and PMCF reports
• Initiate clinical work when necessary to demonstrate intended use, efficacy and safety of our products and equivalence to competition.
• Closely work with Risk Management to ensure that risk management is aligned with clinical affairs
• Integrate clinical affairs processes with the development of new products to ensure that sufficient clinical evidence is available for timely launch of the product
• Prepare reports for the Management Review
• Participate in Notified Body Audits and present clinical documentation
• Preferably deep knowledge in the field of MEDDEV and MDR and preferably other global requirements regarding clinical evaluations, post market surveillance and post market clinical follow-up.
• Experience with clinical research, publications and scientific methods for assessments of clinical studies, within Medical Device or Pharmaceuticals
• Research methodology
• Searching information databases (e.g. Medline)
• Medical writing skills
• Degree from higher education and five years of relevant working experience
• Knowledge of (homecare) ventilators, their technologies and applications is an advantage
• Ability to work on strategic level and to deliver concrete procedures and documentation
• Strong collaboration skills
• Accurate and sense for details
• Fluency in English and preferably Swedish
Please send your application asap to Daniel Kremer, or contact Daniel for questions!