Regulatory Affairs Associate

At the company, we’re Powering the Age of Immune Medicine.   Our goal is to harness the power of the the company 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 the company, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.

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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

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Compensation

Salary Range: $38.56 - $57.88

Other compensation elements to include

• equity grant

• bonus eligible

ALERT: Malicious groups posing as the company employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate the company employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. The company 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?  The company 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!

The company is not currently sponsoring candidates requiring work authorization support for this position.

The company’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.

The company's benefits at-a-glance .

The company 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  [link for members] .

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