Principal Regulatory Scientist (Remote) at Invitae (Formerly ArcherDx)
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.
The Principal Regulatory Scientist focuses on translating scientific and clinical content into effective regulatory submissions and documentation. In collaboration with Clinical Development and Medical Affairs, the Principal Regulatory Scientist provides input on strategic regulatory positioning, implementation of FDA feedback and assessment of criteria captures in regulations, standards or guidance documents from a technical standpoint for Invitae/ArcherDX's diagnostic products.
- Act as a counterpart to the technical functions on behalf of the regulatory team.
- Draft and review content for health authority submissions including, but not limited to: study risk determinations, pre-submission meetings, marketing applications, field correction rationales and clinical trial documentation.
- Advocate for compliance and consistency when presenting technical and clinical documentation to health authorities.
- Work and align closely with regulatory team submission lead to ensure concise and effective positioning of the technical performance of Archer’s diagnostic products.
- Participate in clinical trial monitoring forums and risk management activities to ensure patient safety and ethical considerations are being properly contextualized to actual laboratory environment scenarios.
- Act as a key liaison between assay technical functions and the regulatory team to ensure excellent regulatory content and consistent regulatory positioning of technical performance.
- Minimum 10 years of experience working with genetic sequencing assays in a laboratory environment with a demonstrable expertise in assessing and documenting assay performance.
- Four or more years of experience in developing IVD products and interacting with major health authorities.
- A strong interest in regulatory affairs and a drive to advocate for companion diagnostics and genetic sequencing clinical value with health authorities.
- Strong instincts for systems engineering incorporate multiple key attributes into a well-documented medical device platform.
- Strong working knowledge of 21 CFR 820, ISO 13485:2016, IEC 62304, risk management practices and DHF development.
- Collaborative and positive attitude.
- Working knowledge of global regulatory submissions and typical content included therein.
- Direct experience being interviewed in inspections and audits, and familiarity with audit support practices.
- Must be hands-on, self-directed, organized and conscientious;
- Demonstrated hands on change management leadership skills;
- Excellent written and verbal communication skills;
- Problem solving prowess in consistently evolving environment;
- Proven ability to work under pressure and with short deadlines to accomplish objectives;
- Ability to communicate effectively with technical and non-technical personnel.
- Advanced degree in molecular biology, biochemistry, or related discipline.
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's 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.