Director of Regulatory Affairs and Quality Assurance Europe

| Remote
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Location: Belgium (remote)

Start: ASAP


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. 


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.

 

#LI-RM33

#LI-Remote

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Technology we use

  • Engineering
    • C#Languages
    • C++Languages
    • JavaLanguages
    • JavascriptLanguages
    • PHPLanguages
    • PythonLanguages
    • SqlLanguages

Location

Situated in Austin's Central Business District, one block West of the Texas State Capitol.

What are Invitae Perks + Benefits

Invitae Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Unconscious bias training
Diversity manifesto
Someone's primary function is managing the company’s diversity and inclusion initiatives
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Adoption Assistance
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Sabbatical
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Game Room
Stocked Kitchen
Some Meals Provided
Happy Hours
Parking
Pet Friendly
Recreational Clubs
Home Office Stipend for Remote Employees
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
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