Description du poste et des missions
At Biogen, we develop, market and manufacture therapies for people living with serious neurological, autoimmune and rare diseases. We develop medicines for debilitating medical conditions with the goal of making a meaningful difference in patients’ lives.
We have the leading portfolio of medicines to treat multiple sclerosis (MS), as the first and only approved treatment for spinal muscular atrophy (SMA) and are at the forefront of research into new medicines for neurological and neurodegenerative conditions.
Biogen Digital Health (BDH) is a new global unit of Biogen dedicated to pioneering personalized and digital medicine in neuroscience. At Biogen Digital Health, we aspire to transform Biogen & patients’ lives by making personalized & digital medicine in neuroscience a reality. An integral part of realizing this vision is through developing digital solutions for patients and healthcare professionals (HCPs) in our core disease areas (Alzheimer’s disease, multiple sclerosis, neuromuscular diseases, movement disorders).
As Digital Product Quality Assurance Manager, you will drive the Quality Assurance of BDH solutions through the creation/maintenance of analytical tools and databases to facilitate Pre & Post-Market surveillance, regulatory compliance, product innovation/improvement within the context of an evolving Quality Management System. Each day will offer new challenges as you tackle a variety of tasks to ensure QA and compliance for our products but also monitor industry and regulatory trends to develop a strategy and provide guidance related to these trends in relation to other regulatory departments within Biogen.
What You'll do
Oversight of validation, risk management, documentation & certification of mobile/medical devices (i.e. CE-Marking and FDA Approval)
Manage the Quality Management System processes, including attainment and maintenance of ISO-13485 certification.
Develop Quality metrics and goals
Monitor ongoing BDH compliance for investigational devices across relevant global markets
Monitor industry and regulatory trends to develop a strategy and provide guidance related to these trends
Why Biogen Digital Health?
You will join an international, diverse team of 100+ talented humans who are passionate about making our vision a reality. Our team at Biogen Digital Health rejects the status quo and lives by agile principles. You’ll work directly with an outstanding team of neuroscientists, clinicians, data scientists, biostatisticians, digital product managers, user experience designers, and engineers that work across disciplines to make a lasting impact for patients.
To apply, please follow this link : https://smrtr.io/8GFX7
Who you are
You combine strategic thinking and scientific rigor with exceptional execution, and you strive for excellence in all that you do. You are passionately committed to making a difference in patients’ lives, and you foster a culture of trust and empowerment that encourages openness, ideation, failing forward, and experimentation. You think big, start small, scale fast, and you know that magic happens through diversity of thought, expertise, culture, and background.
● 5 years Quality Assurance Management in the Medical Device Industry
● QA for a Mobile Application
● Significant experience in certification of a medical device (especially outside of US)
● Excellent quantitative and analytical skills
● Ability to prioritize tasks in a fast-paced environment
● Strong written and oral communication skills required
● Fluent in english
Lieu de la mission
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