Regulatory Affairs Associate

Adaptive Biotechnologies; United States; Remote; USD 54,000 - 79,000; Full time

Benefits offered by this job

Equity grant

Bonus eligible

Job summary

Adaptive Biotechnologies in the United States seeks a Regulatory Affairs Associate to support submissions for in vitro diagnostic devices (IVDs) in the US and international markets. You will assist with FDA filings, technical file documentation, and other regulatory materials to help ensure compliant product submissions.

Requirements include a Bachelor’s degree and 2+ years in regulatory affairs; knowledge of FDA guidelines and QSRs is preferred.

Qualifications

• Bachelor’s degree required.
• 2+ years regulatory affairs in the diagnostic or pharmaceutical industry or related field.
• Knowledge of FDA guidelines and quality systems regulation (QSRs) preferred.
• Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories preferred.

Responsibilities

• Assist in writing and implementing process improvements for Regulatory Affairs functions.
• Maintain regulatory document filing and retrieval per SOPs.
• Coordinate and format materials required in submissions, license applications, and technical files.
• Maintain FDA/global regulatory registrations, including communications with agencies.
• Coordinate submissions per FDA/global health authority requirements.
• Assist in creating and implementing regulatory affairs policies and procedures.
• Review project contracts for regulatory requirements as needed.
• Inform cross-functional teams of changes in standards, claims, recalls, adverse events, and impact on IVD products.

Skills

Regulatory affairs

Documentation

Education

Bachelor's degree

Job 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

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 Affi­ citative 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 [e-mail].

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 [e-mail]. 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.