United States onlyAt Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.
As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.
It’s time for your next chapter. Discover your story with Adaptive.
Position Overview
The Regulatory Affairs Manager – IVD/CDx is responsible for developing and executing US FDA and EU regulatory submission activities to support the development and commercialization of in vitro diagnostic (IVD)/LDT and companion diagnostic (CDx) products. This role includes leading the preparation of FDA pre-submissions, IDE, 510(k), PMA, and EU Technical Documentation under IVDR. The manager will collaborate cross-functionally with R&D, Quality, Medical Affairs, and Business Development to ensure regulatory compliance and successful market access.
This is a temporary, full-time position anticipated to last 6-months in duration.
Key Responsibilities and Essential Functions
Collaboration, Team Projects
- Collaboration: Collaborates regularly with internal partners on cross-functional projects. Typically interacts with high-level individual contributors, managers and functional leaders.
- Team Projects: Manages team projects with other team members and may participate in cross-functional projects.
- Works with Minimal Supervision: afterreceiving general instructions on new assignments, works independently to ensure goals are met, escalates issues as appropriate to Senior management.
Regulatory Affairs Responsibilities
- New Product Development: Lead and coordinate the preparation, submission, and maintenance of regulatory filings with the U.S. FDA (Pre-Sub, IDE, 510(k), PMA) and EU Competent Authorities/Notified Bodies (Technical Documentation, Performance Evaluation Reports, and IVDR submissions). Develop and implement regulatory strategies to support companion diagnostic (CDx) programs in alignment with drug development timelines and FDA/CDRH/CDER/Notified Bodies expectations.
- Premarket Regulatory Strategy: Contributes to regulatory plans and strategy; advises how various decisions may affect submissions and associated timelines. Considers relative value of several alternative solutions to potential issues before confirming a final decision as to the path forward
- Change Assessment: Performs timely regulatory assessments to support Adaptive’s change control process, such as need for 510K, notifications, etc. Develop and execute change notification strategies for registered products globally, including US FDA and EU IVDR compliance.
- Regulatory Intelligence: Maintains current knowledge of regulatory requirements in markets for which product/service is offered. Reviews, identifies, and disseminates changes, and collaborates with quality system process owners to interpret applicable regulations and to mitigate any gaps. Monitor and interpret global regulatory requirements for IVDs, CDx, LDTs, and related regulatory pathways in the U.S., EU, and ex-U.S. markets.
- Labelling Review: Reviews labelling for products and services for compliance with regulatory requirements
- Post-market Surveillance: Supports PMS activities by compiling and assessing regulatory information to prepare surveillance reports (e.g. new or revised standards, expanded claims, recalls, adverse events, and impact on products and services)
- Regulatory Processes: Understands processes, procedures and systems used to accomplish work and recognizes downstream impact on other functions or sub-functions. Expert with tools and processes that support work including managing regulatory files, plans, and requirement documents.
- All other duties as assigned
Position Requirements (Education, Experience, Other)
Required
- Bachelors + 8 years of related experience, or Masters + 6 years of related experience
- Hands-on experience with PMA, PMA Supplement, 510(k), Q‑Submissions, IDE, and related FDA filings, and CDx product submission
- 6+ years of regulatory experience in an LDT diagnostics company (e.g., an LDT company with FDA-cleared IVD products), including involvement in drafting submission packages and change reporting submissions (e.g., Technical File updates and/or Supplements).
Preferred
- Experience managing regulatory filings with the FDA, EU, and other ex-US regulatory bodies is highly preferred.
- Experience with regulatory submissions for Companion Diagnostics to the EU and USA.
- Broad knowledge of post-market surveillance regulations, practices, and procedures
- RACS Device Certification
Compensation
Salary Range: $113,500 - $170,300
Possible “other compensation” elements to include:
- equity grant
- bonus eligible
ALERT: Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment.
Interested in this position, but don’t meet all the requirements? Adaptive is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!
Adaptive is not currently sponsoring candidates requiring work authorization support for this position.
Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.
Adaptive's benefits at-a-glance.
Adaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the “Know Your Rights: Workplace Discrimination is Illegal” Poster for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr@adaptivebiotech.com.
If you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please e-mail accommodations@adaptivebiotech.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.
