Compremium is seeking a skilled and highly motivated early-career Quality, Regulatory and Clinical Affairs (QARACA) Specialist to join our team. The ideal candidate will have a strong background in quality assurance, regulatory and clinical affairs within the medical technology sector.
Job Responsibilities and Essential Duties:
As a Junior QARACA Specialist, you will be primarily tasked with supporting the Quality, Regulatory and Clinical teams with:
* Implementing 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.
* Maintaining Compremium’s QMS, including Document Control, SOP compliance and updates, and implementation of QMS updates according to the company’s evolving needs.
* Preparing technical dossiers for Compremium’s products, including development, risk management and testing.
* Crafting clinical trial submissionsfor multiple countries to provide strong evidence supporting regulatory clearance
* Preparing, implementing and updating clinical evaluation plan, report, and post-market clinical follow-up plan and report
* Preparing and submitting regulatory documents, including 510(k) submissions, CE Mark applications, Breakthrough Device Designations, and other regulatory filings, to obtain approvals, clearances and renewals from regulatory agencies.
* Continuous interaction with regulatory bodies, preparing interactive discussions, ensuring timely delivery of Q&A packages
* Ensuring compliance with all relevant regulations, including ISO 13485, FDA, EU MDR, Saudi FDA.
* Provide training and support to staff on quality, 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.
Requirements:
* Master’s degree in a related field (e.g., Biomedical Engineering, Life Sciences, Quality Management, Regulatory and Clinical Affairs).
* 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 would be a plus
* On-site (in Muri bei Bern) with possibility of remote work
Required Knowledge, Skills, and Abilities:
* Minimum of 1 year of experience in:
* Quality assurance and regulatory affairs (e.g. preparing technical documentation and regulatory documents) in the medtech industry, and/or
* Clinical affairs (e.g. preparing for clinical trial submissions, clinical evaluations etc.) in the medtech 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.
* Fast-learning
* Impeccable English, in both written and spoken form. French and German working proficiency are a plus.
* 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.Our first productis cleared by the FDAand CEand is currently used bymultiplereputed institutions in the United States and Europe.Our second product has recently been granted FDA breakthrough designation andis being used by NASA in the International Space Station.We are launching ourproductsin the United Statesand Europe,with a rapid expansion plan to scale quickly.
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