Principal – IVD Regulatory Compliance (ADX-309-20)

| Greater Boulder Area
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Principal – IVD Regulatory Compliance (ADX-309-20)
 
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 Principal – IVD Regulatory Compliance is responsible for ensuring compliance to FDA requirements under the USA Code of Federal Regulations, international standards and other requirements for external agreements, promotional materials and labeling. This position will participate in ArcherDX’s promotional review committee to ensure compliant promotional practices as ArcherDX works to spread the news about its novel diagnostics. Additionally, this position will assist RAQA leadership in acting as a supplemental reviewer on product labeling and partner/supplier agreements which touch on key regulatory requirements such as vigilance reporting, data privacy, and other topics as they arise.
 
RESPONSIBILITIES:
  • Actively participate in ArcherDX’s promotional review committee, including pre-review and live reviews of advertising and promotional materials generated by ArcherDX’s commercial and marketing teams to ensure compliant promotional practices and accurate representations of ArcherDX’s IVD and RUO tests.
  • Research, track and learn relevant industry requirements, both present and future. Communicate relevant impact to stakeholders and spearhead remediation or improvement efforts where needed.
  • As a complement to the Regulatory Affairs team developing submission content, review labeling and public-facing documents for regulatory compliance, accuracy of language and consistency with other ArcherDX content.
  • Assist RAQA management and leadership by reviewing external agreements including, but not limited to, those with suppliers and pharmaceutical partners for overall compliance to current industry standards and requirements, in addition to harmonizing such language to ArcherDX’s typical approach to such matters.
  • Collaborate with ArcherDX’s Legal, Business Development, Alliance Management and other departments to interpret compliance matters typical of the IVD and medical industries.
  • Grow ArcherDX’s compliance expertise by providing and/or delivering training content on compliance matters to ensure organizational competence and prudence while performing their duties both internally and in the field.
  • Consistently work to reduce any compliance risk carried by the ArcherDX organization by supplementing product development and Quality System Regulation activities with holistic global IVD compliance. Contribute input to these systems where appropriate to ensure ArcherDX avoids “surprises” of unexpected requirements.
EXPERIENCE: 
  • 8 or more years supporting and/or operating in a role governed by a medical device or IVD QMS.
  • 3 or more years of high accountability for decision making in compliance matters.
  • High preference for candidates familiar with the IVD, CAP/CLIA, and RUO testing compliance/regulatory landscape.
  • High familiarity with reviewing documents and providing feedback.
  • Aptitude for professional confidence to provide concrete and actionable advice to all levels of an organization.
  • High degree of proficiency with document and presentation creation.
  • Familiarity medical device and/or IVD design control and QMS processes.
  • Fine research skills with a knack for sketching out solutions to novel issues to engage in educated decision making even when navigating the unfamiliar.
  • 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
  • Advanced degree in healthcare policy, regulatory affairs, law or similar field preferred.
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Technology we use

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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 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 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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