Manager, Regulatory Affairs

How would you like to grow your skills working for a mission-driven organization while playing an important role in doing more with life? AlloSource is one of the top 10 BioTech companies in 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:

Ensure that the regulatory requirements and company organizational goals are effective and in compliance. Provide expertise and guidance regarding domestic and international regulatory and quality requirements needed to meet product development projects, complaints, adverse reactions/events, field actions, regulatory reporting, internal and external auditing, supplier quality, document preparation, performance metrics and review of certain controlled documents. This position also provides guidance to AlloSource customers and AlloSource personnel.

Application Deadline: April 22, 2024 (1:00PM MST)

Pay: $87,067.20/yr. – $109,007.83/yr. based on relevant years of experience

Shift: Monday-Friday; 8:00am – 5:00pm

Benefits: Medical, Dental, Vision, Life Insurance. Click link for more benefits details:

Location: This is a Hybrid role: 3 days in office; 2 days work from home. (6278 S Troy Cir Centennial, CO 80111)

(Relocation assistance offered at 15% of salary amount)

Essential Duties and Responsibilities:

Develop, implement, and maintain procedures in support of regulatory compliance.

Assist with the development and implementation of regulatory strategies for existing, new, and modified products.

Provide review and approval of product and process changes, as required, to ensure compliance with regulatory requirements.

Assist in developing and documenting sound regulatory decisions and justifications and advising organization on impact of changing regulations.

Assist with the creation and maintenance of regulatory documents and claims, and up to date (regulatory changes, business changes, new indications) labeling for products.

Review and approval of labeling and marketing collateral.

Assist with the timely preparation and submission of domestic and international regulatory submissions (i.e. product related submissions, facilities related submissions).

Oversee Post-market reporting system.

Oversee Audit Program (regulatory bodies, customers, internal).

Oversee Supplier Quality program.

Provide guidance to staff in Regulatory and inspection matters.

Assist as a resource in Regulatory and Quality department planning and budgeting.

Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.

May perform other related duties and responsibilities as assigned.

Requirements

Bachelor’s degree

In lieu of degree, 9 years’ experience working in Regulatory Affairs

5-7 years’ regulatory/quality experience in an FDA regulated industry in the medical product space (ex: tissue banking, medical device, biologics or pharmaceutical)

3-5 years’ supervisory experience

Previous experience preparing and submitting regulatory product submissions (i.e. TRG, 510(k), PMA, IND, BLA)

Direct experience with multiple Quality Systems and Regulatory Affairs processes, e.g. CAPA, Complaints, Post-market reporting, product development, pre-market regulatory submissions

Previous audit participation and/or oversight of internal audits, regulatory audits, or supplier audits

Proficiency in Microsoft Office applications

Preferred Experience:

Regulatory Affairs certification (RAC)

7+ year’s regulatory/quality experience in an FDA regulated industry in the medical product space

Indirect experience with related business functions such as operations/manufacturing, research & development, marketing and/or sales

Experience with Risk Management systems [ISO 14971]

Experience in managing Medical Device Quality Systems [ISO 13485, 21 CFR 820]

Experience in managing Biologics [21CFR 210/211] Quality Systems

Experience in managing supplier quality systems

Click Link for Full Job Description: Manager, Regulatory Affairs

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 .

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

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