Manager - IVD Regulatory Operations at Invitae (Formerly ArcherDx)

Sorry, this job was removed at 11:26 a.m. (MST) on Wednesday, July 21, 2021
Find out who's hiring in Colorado.
See all Operations jobs in Colorado
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

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 genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

POSITION SUMMARY:

The Manager, IVD Regulatory Operations will be responsible for managing global regulatory compliance of Invitae’s IVDs and companion diagnostics.  The position will create and execute operational strategies that support commercial expansion and enable continued compliance.  For globally marketed products, this position will oversee ongoing complaint and vigilance reporting to health authorities around the world, including the USA.


RESPONSIBILITIES:

  • Assist with the development and implementation of regulatory procedures, particularly focused on proper documentation for medical device registration both outside and within the USA.
  • Create draft planning documents to guide project teams on regulatory documentation requirements for a given region or country.
  • Provide or arrange for training and informational materials to help Archer project teams with successful foreign registration.
  • Identify and manage external partners such as authorized representatives, in-country agents, translation services, CROs and regulatory consultants.
  • Lead the development and maintenance of product labeling, including the requirements of UDI and EUDAMED.
  • Maintain the process to track product renewal and/or re-registration dates to ensure products remain in compliance with the appropriate country requirements.
  • Maintain and monitor the New or Changing Standards or Regulations process (NCSR) and ensure involvement of the appropriate cross-functional groups.
  • Ensure Invitae's compliance to post-market requirements, such as complaint reporting, in regions where Invitae sells regulated IVD products.
  • Represent Invitae at regulatory meetings in-person, abroad and remotely, and interact with pharmaceutical and foreign regulatory partners as needed.
  • Assist in the hosting of audits by regulatory authorities.
  • Develop and manage an international regulatory affairs team along with a high functioning post-market vigilance team which partners with other cross-functional representatives.
  • Perform other duties as assigned by supervisor, including case-by-case general compliance matters.

 

 

 

EXPERIENCE: 

  • Six or more years of experience in generating submissions, technical files, or other documentation in support of medical device/IVD registration globally.
  • Three or more years building and supervising a successful regulatory team.
  • Previous regulatory affairs operations experience preferred.
  • Strong regulatory strategic thinker with the skills to present resourcing, timeline and tradeoff scenarios to company leadership regarding global deployment of regulated products.
  • High degree of proficiency with MS Office and Adobe PDF creation.
  • Preference for candidates with language skills beyond English.
  • Familiarity with medical device and/or IVD design control processes
  • Experience with good manufacturing practice and good document practice.
  • Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
  • Fine research skills with a knack for sketching out solutions to novel issues
  • Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
  • Ability to work independently, and report progress efficiently.
  • Ability to multitask and work within a fast-paced dynamic team environment

EDUCATION:

  • Minimum B.S./B.A, preferably in a technical field.

In Colorado, our competitive compensation package includes a base salary starting from $129,000. In determining the final salary offered we will evaluate a specific candidate geographic location, education, skills and experience.

 

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

  • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
  • Paid time off, holiday pay, parental leave, and other health and wellness supports

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.

Read Full Job Description
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

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
More Jobs at Invitae (Formerly ArcherDx)75 open jobs
All Jobs
Finance
Data + Analytics
Design + UX
Dev + Engineer
HR + Recruiting
Internships
Legal
Marketing
Operations
Product
Project Mgmt
Sales
Developer
new
Remote
Operations
new
Remote
Developer
new
Remote
Data + Analytics
new
Remote
Product
new
Boulder
Developer
new
Boulder
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Developer
new
Remote
Data + Analytics
new
Remote
Developer
new
Remote
HR + Recruiting
new
Remote
Developer
new
Remote
Data + Analytics
new
Remote
Operations
new
Remote
Operations
new
Boulder
Developer
new
Boulder
Operations
new
Boulder
Project Mgmt
new
Boulder
Developer
new
Boulder
Internships
new
Boulder
Operations
new
Boulder
Operations
new
Boulder
Operations
new
Boulder
Internships
new
Boulder
Project Mgmt
new
Boulder
Developer
new
Remote
Developer
new
Remote
Marketing
new
Remote
Data + Analytics
new
Remote
Developer
new
Remote
Product
new
Boulder
Design + UX
new
Remote
Operations
new
Remote
Operations
new
Boulder
Data + Analytics
new
Remote