Sr. Regulatory Affairs Specialist- Software at Invitae (Formerly ArcherDx)

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Sr. Regulatory Affairs Specialist-  Software

Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life.

Our team is expanding rapidly and we’re looking for people who are passionate about helping improve healthcare to join us.

This position will work with a team of scientists, software engineers, quality and regulatory affairs experts and is responsible for assessing software products for regulatory requirements worldwide. In this role you will provide guidance to development groups and act as the subject matter expert on software regulatory requirements. You will support and lead software regulatory compliance and submission process development and improvements. The candidate needs to be a quick learner to keep up with fast developments at Invitae.

What you will do:

  • Assess software products for regulatory requirements worldwide and give guidance to software development teams.
  • Work with subject matter experts to compile technical documentation in support of global registrations.
  • Act as a subject matter expert on software regulatory requirements, including documentation, validation and verification, cybersecurity.
  • Support or lead process development and improvement activities related to software regulatory compliance and submissions.
  • Develop and manage US regulatory submissions for software products.
  • Other regulatory support tasks as assigned, such as review of promotional/scientific or labeling materials.

Who you are:

  • The successful candidate for the position will have a Bachelor’s degree preferably in life sciences, advanced degrees (MS/PhD) are strongly preferred with a minimum of 5 years experience working in Regulatory Affairs relevant to medical device and/ or IVD products, preferably including software products
  • Must have experience with technical documentation and will have the ability to read, analyze, and interpret technical documents, professional journals, technical procedures and government regulations.
  • Solid understanding of Quality System Regulation (QSR) requirements.
  • Expert use of Microsoft Word, Excel, PowerPoint, and experience with document management systems and document sharing systems.
  • Problem solving skills, motivation, good judgement, ability to manage multiple tasks.
  • Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style.
  • Excellent communication and teamwork skills, and the ability to adapt and interface effectively with a wide range of stakeholders.
  • Experience with project management and/or process improvement is a plus. 

By joining Invitae, you’ll work alongside some of the world’s experts in genetics and healthcare at the forefront of genetic medicine. We’ve created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization.

Join us.

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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Technology we use

  • Engineering
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • RubyLanguages
    • SqlLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • ReactLibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • MongoDBDatabases
    • 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 Invitae (Formerly ArcherDx)

What’s the vibe like in the office?

Collaborative - when I walk through the Invitae 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 Invitae. 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 Invitae (Formerly ArcherDx) Perks + Benefits

Invitae (Formerly ArcherDx) 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
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
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)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Restricted work hours
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning
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