The Regulatory Affairs Manager is a critical link between PTT and Regulatory Authorities. This position works with diverse and cross functional groups at PTT including but not limited to, product development, production, fellow Quality Systems colleagues, and regulator professionals. She/he oversees the regulation process for products requiring regulatory approval, including filing necessary applications and handling all government interactions. This position oversees the coordination of inspection and audits of the organization and contract facilities and develops procedures to ensure regulatory compliance.
Key Interactions and Relationships
Regular direction and oversight of Regulatory Affairs teams to ensure tasks and projects are executed in an effective, timely manger aligned with company initiatives
Regular communication, verbally and written, with Regulatory Authorities and/or Third-Party Reviewer and/or distributors to achieve positive outcome in license application and registration approvals
Consistent communication with customers in terms of audit closure (e.g. corrective action close-outs)
Maintain open, regular communication with appropriate PTT personnel concerning quality and/or regulatory issues
Ongoing training and development of staff to ensure compliance as it relates to regulatory affairs
Duties and Responsibilities
Prepare and or review routine regulatory applications and submissions such as establishment registrations, annual registrations, state license renewal, drug/device listings, and other registrations including customer requests for regulatory information.
Prepare and maintain US 510(k) and international regulatory submissions, including assist in authoring and preparing pre-submissions, Regulatory Master Files, Technical Files / Design Dossier documentation as required in compliance with the FDA and international regulations and guidelines.
Maintain regulatory files/database effectively, and in accordance with standards and best practices.
Establish and maintain system for tracking documents submitted to agencies or partners.
Maintain well-organized, auditable regulatory files and assist in the development of regulatory strategies.
Provide ongoing, timely and accurate regulatory affairs support to product development teams working to realize new and modified product designs in accordance with company policies and procedures.
Provide regulatory assessments/review for post-approval design, manufacturing and labeling changes.
Review product labeling for accuracy and compliance with regulations.
Review regulatory documents for submissions to regulatory agencies.
Interact and interface with regulatory agencies as necessary.
Read, review, interpret and keep current with regulations, recognized standards, and publications regarding all PTT products.
Participate/assist with regulatory, accreditation or Customer assessments/audits/inspections.
Assist in drafting responses to external assessments/audits/inspections
Assist with the performance of internal and external audits.
Track and Follow-up with all PTT staff with open Deviations and Corrective Actions Reports.
Track due dates for and perform and document effectiveness checks for corrective actions implemented.
Assist in identification of reoccurring systemic problems and track/research trends.
Provide support in maintaining adverse event handling system; Provide support in product notification and recall activities.
Assist and/or perform special projects to support continuous improvement companywide.
Perform regulatory research and stay abreast of new/emerging regulations and communicates relevant changes to RA management and project teams.
Maintain current knowledge of FDA and international regulation, guidance and standards applicable to PTT products.
Organize and prioritize work with minimal guidance and manage work in a timely and effective manner.
Provide periodic data/metrics reports and assemble information for Management Review.
Handle agency and customer interactions including recalls and strategy which includes getting products into new markets and working with emerging indications for new regulatory approvals for the product types including new product uses with minimal guidance.
Responsible for preparing regulatory positions for customers and regulatory bodies as assigned.
Provide ongoing training and development to entry level staff to ensure compliance as it relates to regulatory affairs.
Other duties as assigned by the Director of RA/QA that may include administrative tasks such as filing, data analysis and related special projects
Knowledge, Skills, and Abilities Required
English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government— Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Oral and Written Communications — Conveying information and ideas so others will understand. Proven ability to communicate complex ideas in a clear, concise manner.
Organization- Excellent documentation, organization and follow-up skills, should have the ability to reorganize and reschedule work on short notice in order to meet revised deadlines or company needs.
Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Complex Problem Solving — Identify complex problems and reviewing related information to develop and evaluate options and implement solutions.
Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Law and Government — Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, as it related to tissue banking.
Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Active Listening — giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Evaluating Information to Determine Compliance with Standards— Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
Physical Environment & Working Conditions
Full Time position (40 hours or more) based in Arizona
Position will be occasionally required at times to work in a clean room environment where protective clothing such as hoods, face masks, gloves, boots, and coveralls are required
Equipment & Machines Used
Desktop computer and general office equipment.
The Regulatory Affairs Manager is expected to maintain confidentiality of all donor/recipient information.
Essential Education and Work Experience Requirements
A Bachelor’s Degree in a science or related field is required
4-7 years’ experience as an individual contributor in US and/or non-US regulatory affairs including regulatory submissions, auditing principles and investigation skills, preferably in tissue bank industry, required
3-5 years of regulatory management experience in tissue banking or a regulated medical device or pharmaceutical company preferred
Experience with FDA, EU and other international regulations
Experience and knowledge of tissue-banking regulations and AATB standards is a plus. Must have CTBS certification or be willing to obtain CTBS within 1 year of hire
Regulatory Affairs Professional Society Member and Certifications a plus.
Internal Number: 001
About Pinnacle Transplant Technologies
Founded in 2010, Pinnacle Transplant Technologies (PTT) recognized the need to establish a processing and distribution facility that would enable medical professionals to acquire safe quality allograft tissue for transplant. The company manufactures innovative allografts produced to the highest standards of quality and safety. With a dedication to customer service, we are devoted to being the most responsive and accommodating Tissue Bank in the industry. Learn more about our specific products.
Pinnacle Transplant Technologies is a multi-service tissue bank dedicated to the ethical participation in the Donate Life ™ process. U.S. Food and Drug Administration (FDA) registered and American Association of Tissue Banks (AATB) accredited, Pinnacle only works with federally chartered Organ Procurement Organizations (OPOs) and agencies accredited by AATB to help provide superior allografts for transplantation, assure transplant patient safety, safeguard our associates, and assure reverence to our donor families.