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
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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