Director of Regulatory Affairs and Quality Assurance Europe at Invitae
Location: Belgium, Netherlands, Germany or France (remote)
Invitae is a rapidly growing medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve the quality of healthcare for billions of people.
We are a multidisciplinary company executing a novel business model in a highly technical, highly regulated, and overly complex industry against a backdrop of rapid and disruptive technological advancement. Patients are at the center of everything we do, while we continually seek to improve and grow in efficiency and strive to produce consistent and reliable results.
At Invitae, we’re building an organization that can continuously innovate at scale. Equally importantly, we’re building a company where we love to work. As a team, we pride ourselves in having a diverse group of individuals who collaborate and work well together so that we can learn and grow from one another. We rely on each other to work with a sense of urgency and with a goal of putting the team above the individual.
As you join team Invitae, you are expected to help us grow and modify our culture over time, and most importantly, to challenge us when we are not living up to it. It’s important to keep in mind that we craft and maintain our culture to serve our mission, and we will adjust our culture from time to time to optimize the pursuit of that mission.
About the role
To pursue our shared mission and help Invitae grow, we are looking for a Director of Regulatory Affairs and Quality Assurance, EU.
This position 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.
What you will do:
- 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.
What you will need
Minimum 12 years of experience in management or lead role for regulatory or quality functions in Europe.
- Advanced degree relevant to laboratory testing or biomedical product development;
- 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).
Interested in this position? Please apply online by sending us your CV in English
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.
Invitae retains your application data for 12 months to process your job application and produce anonymised monitoring statistics. After 12 months, your data will automatically be deleted. In addition, you have the right to request your personal data be deleted, updated or removed at any time. You also have the right to have a copy of the information Invitae holds about you. You can make such requests by emailing [email protected]
Get to know us!
Do you want to know more about us and how we are changing the genetics industry?
- Visit our website Invitae.com
- Check out Invitae’s YouTube Channel
- Follow us on Twitter, Facebook, or Instagram
/!\ Staffing and Recruiting Agencies /!\
Contact from Staffing and Recruitment Agencies are not appreciated and will be automatically disregarded.
Our vacancies are only intended for individuals.
Staffing and recruiting agencies and individuals being represented by an agency will be considered unsolicited. We do not accept unsolicited CVs or applications from agencies other than preferred suppliers.