Regulatory Affairs Specialist - Solid Tumor (ADX-53-20)

| Greater Boulder Area
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Regulatory Affairs Specialist - Solid Tumor (ADX-53-20) 
 

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 Regulatory Affairs Specialist, reporting to the Sr. Regulatory Affairs Manager for the Solid Tumor program, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for the US and OUS submissions. This position will primarily support Archer’s Solid Tumor program focused on bringing a kitted IVD solution to the targeted oncology therapy market.
 
RESPONSIBILITIES:
  • Operate as the primary contact for regulatory submissions, including, but not limited to, pre-submission meetings and marketing applications.
  • Support submission writing activities across the program.
  • Assist the Solid Tumor clinical collaborations by providing compliance and trial design expertise.
  • Assist with the development and implementation of regulatory procedures.
  • Take on assignments from project core teams and support other initiatives on a departmental basis.
  • Maintain marketing authorizations and approvals through change management and, if necessary, drafting and submission of supplements or change notifications to regulatory authorities.
  • Review of the documentation associated with the support and continued manufacturing for Companion Diagnostics.
  • Perform other duties as assigned by supervisor.
EXPERIENCE:
  • High degree of proficiency with MS Office and Adobe PDF creation.
  • Demonstrable, hands-on experience with substantial medical, technical or regulatory writing. A writing sample is welcome.
  • Experience writing FDA marketing applications (e.g. PMA, de novo 510(k)) for IVD products, acting as the primary submission author and/or RA core team representative.
  • Four (4) or more years of regulatory affairs experience in medical devices.
  • Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
  • Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
  • Ability to work independently, and utilize good problem-solving skills
  • Ability to multitask and work within a fast-paced dynamic team environment
EDUCATION:
  • Minimum B.S./B.A.
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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

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

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 Stand-up
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
Employees who have been with the company for 12 months are eligible for 12 weeks of 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
Promote from Within
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