Senior Regulatory Affairs Specialist at Invivoscribe
Click the link here to apply: https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=b6855c59-4e4c-4ef7-a245-3e6e8e39e7ae&ccId=19000101_000001&type=MP&lang=en_US&jobId=522664
Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years.
Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries.
Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments.
For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started!
We are looking to add a Senior Regulatory Affairs Specialist to our team. The Senior Regulatory Affairs Specialist leads regulatory compliance objectives for the Invivoscribe family of companies, with the main focus being that regulatory submission projects are completed on time and that related technical
documentation files are maintained.
Core Responsibilities Include:
▪ Responsible for generating submissions to the FDA, NB and ROW agencies.
▪ Assesses appropriateness of Design Control documents.
▪ Maintains Technical Files.
▪ Submits required adverse event reports.
▪ Submits required annual reports.
▪ Participates in Project Core Teams and provides regulatory guidance to other departments.
You Bring:
▪ B.S. degree in a technical or scientific discipline with, typically, 5+ years of experience, ideally in a Regulatory department (medical device or pharmaceutical). An equivalent combination of education and experience will be considered.
▪ Experience authoring successful registration submissions.
▪ Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs.
We Bring:
▪ A beautiful modern facility centrally located in San Diego County, with many jobs conducive to a hybrid work from home arrangement.
▪ A safe, fully-vaccinated, work environment.
▪ A diverse and inclusive work environment where you will learn, grow, and make new friends.
▪ A well-stocked breakroom with hot and cold beverages, snacks, refrigerator and pantry items to get you through the day.
▪ Competitive salaries and bonus program, incentive stock options, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating holidays.
Invivoscribe is an Equal Opportunity Employer.
Evidence of COVID-19 vaccination will be required as a condition of employment.
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