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, document preparation, performance metrics and review of certain controlled documents. This position also provides guidance to AlloSource customers and AlloSource personnel.
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.)
- 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.
- Bachelor’s degree in Regulatory Affairs, Life Sciences, or a related field
- 5-7 years’ regulatory/quality experience in an FDA regulated industry in the medical product space (ex: tissue banking, medical device, biologics or pharmaceutical)
- 5 years’ supervisory experience in an FDA regulated environment in the medical product space.
- 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
- Must be competent in conducting regulatory research, reading and interpreting regulatory documents.
- Requires excellent written and verbal communication skills, business savvy, and ability to work with staff from all levels of the organization.
- This position requires a high degree of discretion and judgment in carrying out the job tasks and responsibilities. As this job functions with a very high degree of independence, the incumbent is expected to make decisions based upon knowledge and experience, with the safety of customers and the safety and integrity of AlloSource always at the forefront of consideration.
- This position will generate as well as have direct access to highly confidential AlloSource information such as IP, audit reports, new product ideas/protocols, and contracts.
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. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
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.