Position Details
QARA Specialist
Full-Time
Switzerland
Quality Management
Job Overview
Compremium is seeking a skilled and highly motivated early-career QARA Specialist to join our team. The ideal candidate will have a strong background in quality assurance and regulatory affairs within the medical technology sector. The successful candidate will maintain our digital Quality Management System, assist in the preparation of the technical documentation and regulatory submissions, and help with its transformation into a fully integrated QMS solution.
Join us in our journey and make a meaningful impact on the lives of patients and healthcare professionals!
Responsibilities & Essential Duties
Implement Compremium’s regulatory strategies as per the plan provided by our QM to guide the development, approval, and commercialization of medical devices in compliance with relevant regulations and standards
Maintain Compremium’s QMS, including Document Control, SOP compliance and updates, and implementation of QMS updates according to the company’s evolving needs,
Prepare and submit regulatory documents, including 510(k) submissions, CE Mark applications, and other regulatory filings, to obtain approvals and clearances from regulatory agencies.
Assist in the preparation of technical documentation, including development, risk management and testing
Ensure compliance with all relevant regulations, including ISO 13485, FDA, and EU MDR.
Prepare and submit regulatory documentation for product approvals and renewals.
Provide training and support to staff on quality and regulatory requirements.
Stay up to date with changes in regulatory requirements, guidelines, and industry best practices, and advise the organization on potential impacts.
Cross-functional collaboration: Collaborate with the different stakeholders to contribute to company culture and growth.
Minimum Requirements
Master’s degree in a related field (e.g., Biomedical Engineering, Life Sciences, Quality Management).
Strong understanding of medical device regulations and standards, such as FDA regulations (21 CFR), ISO 13485, and MDR.
Experience in preparing and submitting regulatory documents and interacting with regulatory agencies.
Fast-learning
Impeccable English; German and French working proficiency are a plus.
On-site (in Muri bei Bern) with possibility of remote work
Required Knowledge, Skills, & Abilities
Minimum of 2 years of experience in quality assurance and regulatory affairs in the medical technology industry.
Excellent understanding of medical device development processes with emphasis on compliance with norms, regulations and quality management
Detail-oriented with a commitment to maintaining high standards of quality.
Ability to work independently and as part of a team.
Excellent verbal and written communication skills
Ability to work with internationally located QM specialists of Compremium suppliers
Demonstrates passion and enthusiasm for the company’s vision and work
Ability to manage/prioritize multiple projects and adapt to a changing, fast-paced environment
About Compremium AG
Compremium is a medical diagnostics company based in Bern, Switzerland. We are on a mission to transform the diagnosis of pressure-related conditions in the human body with our first-of-its-kind, non-invasive platform technology. The device is cleared by the FDA and is currently used by NASA on the International Space Station and in other reputed institutions in the United States and Europe. We are currently launching our device in the United States, which is our first go to market, and we have an ambitious expansion plan to scale rapidly.
