Director of Regulatory Affairs and Quality Assurance Europe
The Director of Regulatory Affairs and Quality Assurance, EU oversees the establishment of successful programs for IVD CE-marking, quality system certification, post-market vigilance and compliant manufacturing and distribution.
Belgium is the preferred location for this position.
- Stewardship of European RA/QA organizational initiatives, resourcing and compliance to IVDD/IVDR requirements per local competent authority interpretation.
- Representation of Archer in the European market via interactions with regulators, pharmaceutical/clinical partners and customers.
- Determine and facilitate regulatory strategy for all products, including, but not limited to, pre-submission interactions and marketing applications
- Lead IVD submission development for CE marking and performance evaluation
- Accountability for RA/QA success and growth in a manner that represents the commitment to bringing novel and effective oncology testing to Europe.
- Act as a primary stakeholder and voice on policy and regulatory matters on behalf of the rapidly changing European IVDR environment.
- Minimum 12 years of experience in management or lead role for regulatory or quality functions in Europe.
- Experience hosting, facilitating and addressing quality inspections by competent authorities and notified bodies.
- Direct experience authoring and managing documents for CE marking under IVDD/IVDR.
- Experience in developing a culture of compliance and safety for medical devices.
- Ability to facilitate multilingual conferences and document drafting.
- Fluent in English and preferably an additional EU major language (e.g. German, French)
- Advanced degree relevant to laboratory testing or biomedical product development
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
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Job posted: 2021-04-07