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.
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.
- 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.
- 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
- Minimum B.S./B.A
- Advanced degree in healthcare policy, regulatory affairs, law or similar field preferred.
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