Regulatory Affairs Associate
Adaptive Biotechnologies
39 - 58 / hour
Need a reasonable accommodation to apply or interview? Contact us.
JobMinglr uses automated technology to recommend jobs based on profile information and job preferences. Match Score does not determine eligibility for a position, prevent a user from viewing or applying to a job, or make hiring decisions on behalf of an employer.
Description
At 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 Associate is responsible for assisting with assembling the regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and in international markets. This role also helps maintain FDA submission files and records, ex-US technical file documentation, and other documents and policies that support regulatory activities.
Key Responsibilities and Essential Functions
- Assists in writing and implementing process improvements for Regulatory Affairs functions
- Maintains and performs regulatory document filing and retrieval in conjunction with SOPs
- Compiles, coordinates, and formats materials required in submissions, license applications, technical file documentation etc.
- Maintains files related to FDA/global regulatory registrations, including communications with FDA/Global regulatory agencies
- Coordinates and formats submissions per FDA and/or other global health authority requirements
- Assists in the creation and implementation of regulatory affairs department policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Support operations by reviewing incoming project contracts and provide guidance for regulatory requirements for projects, as required
- Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product
- All other duties as assigned
Position Requirements (Education, Experience, Other)
Required
- Bachelor’s Degree
- 2+ years of experience in regulatory affairs in the diagnostic or pharmaceutical industry, regulatory science or related degree or certification, or other related experience
Preferred
- Demonstrates knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output. Knowledge of FDA and quality systems regulation (QSRs)
- Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories
#LI-Remote
Compensation
Salary Range: $38.56 - $57.88
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.
Benefits
- stock options
About this role
Adaptive Biotechnologies is hiring a Regulatory Affairs Associate to support the submission and compliance work needed to bring in vitro diagnostic devices to market in the US and internationally. You'd spend your time assembling regulatory submissions, maintaining FDA files and technical documentation, coordinating materials according to health authority requirements, and helping develop department policies and procedures. The role also involves flagging regulatory changes, adverse events, and compliance issues to cross-functional teams and reviewing incoming contracts for regulatory implications.
The position requires a bachelor's degree and at least two years of regulatory affairs experience in diagnostics, pharmaceuticals, or a related field. Familiarity with FDA guidelines and quality systems regulations is important; prior exposure to IVDs, molecular diagnostics, PCR assays, sequencing, or CLIA labs is a plus. This is a remote, full-time role with a salary range of $39–$58K, plus equity and bonus eligibility. The work suits someone detail-oriented who can manage documentation, coordinate across teams, and stay current with regulatory requirements in a fast-moving biotech environment.
Pay for this role
$39 to $58 per hour
That is the employer's posted range, and where you land in it is usually decided in one conversation. Before that conversation, run the numbers: analyze an offer for this role.
Before you apply, worth reading
How JobMinglr reads this job
Every listing here is scored against your profile before you apply: skills overlap, experience level, location and work arrangement, each weighted and explained. You see the score and the reasons, not just a list. How the matching works.