Regulatory Affairs Specialist

Overview

How would you like to develop your skills working for a mission-driven organization while playing an important role in doing more with life?  AlloSource is a BioTech company headquartered in Centennial, Colorado.

Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families, and helping patients heal through our innovative cellular and tissue allografts.  This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life!  What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life!   If this sounds like an organization you wish to be a part of, then we invite you to apply.

Summary: 

Provide support for domestic and international registrations. Support regulatory submissions and maintain regulatory file documentation. Assist with internal audits, regulatory and customer audits. Limit decisions to areas of expertise and seek input from VP/Director, RA/QA and subject matter experts as necessary.

Anticipated Application Deadline:    March 12, 2025 (1:00PM MST)  

Pay:  $62,973/yr   -  $73,473   based upon relevant years of experience

Shift:   Monday -Friday;  8;00am  to 5:00pm    Hybrid work schedule - working 3 days in the office, 2 days from home. 

Benefits:   Medical, Dental, Vision, Life Insurance. Click link for more benefits details:    2025_AlloSource_BenefitGuide-20241023195437.pdf

Location:   6278 S Troy Circle Centennial, CO  80111

Essential Duties and Responsibilities:

• Provide assistance to ensure compliance to manufacturing & distribution registration and licensing requirements by compiling information required to manage Federal and State certifications and licenses for tissue banking.
• Assist with compiling documentation in support of new product development, and domestic and international regulatory submissions/files/documentation.
• Assist with review and approval of product labels, inserts and other labeling to ensure adequate information, instructions, cautions and warnings are present and that all labels/labeling are in conformance with regulatory requirements and pre-market clearances, as applicable.
• Assists in compilation of documents to maintain documentation regarding AATB label requirements.
• Participate in internal audits as required.
• Interact with internal and external customers & regulatory bodies and assist with customer and regulatory audits as required.
• Assist with Quality System projects, Corrective and Preventive Actions, Nonconformance investigations, complaints and adverse events/reactions reports/investigations or other failure investigations. 
• Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
• May perform ohter related duties and responsiblities as assigned 

Requirements

• Bachelor’s degree
• In lieu of degree, 7 years’ experience working in a regulated industry
• 3-5 years’ working in a regulated industry
• A working understanding of Quality systems, FDA regulatory requirements, and AATB Standards
• Previous experience in a position that required multi-department interactions
• Proficiency in Microsoft Office applications
• Ability to communicate in English proficiently (speaking, reading, writing, and comprehension)

 Preferred Experience:  

• Tissue banking, medical device, biologics or pharmaceutical
• 2 years’ experience in quality assurance or regulatory affairs

Click Link for Full Job Description:    Regulatory Affairs Specialist                 

It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. When needed we will provide reasonable accommodations to qualified applicants and employees so that they may perform the essential job duties of the position. If you require special accommodations, please contact us at 720-873-0213. 

For consideration you must apply online, submit a current resume and meet the minimum requirements.  AlloSource is a Fair Chance Employer.  Candidates within a 50 mile radius of the hiring zip code may receive first consideration.

Equal Opportunity Employer/Veterans/Disabled

AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

Salary : $62,973 - $73,473