Sr. Manager - International Regulatory Affairs (ADX-180-20) at Invitae (Formerly ArcherDx)

| Greater Boulder Area
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Sr. Manager - International Regulatory Affairs (ADX-180-20) 
 

THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

 
POSITION SUMMARY:
 
The Sr. Manager, International Regulatory Affairs and Vigilance Reporting will be responsible for managing relationships with foreign regulatory agents and seeing international submissions for genomic devices and IVDs including companion diagnostics to a successful conclusion. 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 outside the USA.
  • Create draft planning documents to guide project teams on regulatory documentation requirements for a given region or country.
  • Identify and manage external partners such as authorized representatives, in-country agents, translation services, CROs and regulatory consultants.
  • Ensure Archer’s compliance to post-market requirements, such as complaint reporting, in regions where Archer sells regulated IVD products.
  • Provide or arrange for training and informational materials to help Archer project teams with successful foreign registration.
  • Represent Archer 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 outside the USA.
  • Three or more years building and supervising a successful regulatory team.
  • 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 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.
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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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