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.
Pay: $79,152- $126,787.50/yr based on relevant years of experience
Bonus: 10% target Bonus Program based on individual and company metrics
Shift: Monday-Friday; 8:00am – 5:00pm
Benefits: Generous Time Off Policy, Paid Sick Leave, 9 paid Holidays, Retirement Plan, onsite Health Care clinic, Wellness Program, Life Insurance, AD&D, Short & Long Term Disability, and more!
Location: 6278 S. Troy Circle, Centennial, CO 80111 (REMOTE opportunities available but the candidate will need to be a local resident)
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. Interpret product, policy and process changes to ensure compliance with regulatory requirements.
- 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 to ensure substantiation of claims, adequate information, and cautions/warnings are present and that all labeling is in conformance to regulatory requirements in accordance with Federal, state, and other applicable regulatory and quality requirements.
- Assist with the timely preparation and submission of domestic regulatory submissions (pre and post market), and submission of Technical Files and/or international regulatory submissions, as well as internal regulatory file documentation, ensuring they meet appropriate standards and content requirements.
- Oversee Complaint Handling, Adverse Reaction/Event Reporting, Deviation reporting, Recall, and Regulatory License/Registration systems.
- Oversee internal audit system (Schedule, create checklist, communication, opening meetings, conduct audits, closing meetings, creating audit report, maintain internal/external audit files and records, and overseeing corrective actions.)
- Oversee Supplier Quality program
- Host customer audits (plan, document and act as primary contact) and respond to audit findings.
- Ensure completion of customer quality/regulatory surveys, maintain survey files.
- Develop/provide reports for applicable quality metrics.
- Oversee regulatory audits & responses in cooperation with, Regulatory and Quality Leadership.
- 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.
- Bachelor’s degree in Regulatory Affairs, Life Sciences, or related field
- In lieu of degree, 9 years’ experience 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
- Experience working in or managing cross-functional teams
- Previous audit participation and/or oversight of internal audits, regulatory audits, or supplier audits
- Proficiency in Microsoft Office applications
- Regulatory Affairs certification (RAC)
- Master’s degree in Regulatory Affairs, Life Sciences, or a related field
- 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
- Experience creating and utilizing process maps
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. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. 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/Disability
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.