Pinnacle Transplant Technologies is seeking a strong leader with demonstrated success leading a Regulatory Affairs/Quality team in the tissue banking industry. This role will be a critical pillar in our mission of honoring the gift of donation and commitment to the highest levels of quality.
How you will contribute to PTT's mission:
The Director of Regulatory Affairs/Quality Assurance is responsible for planning, directing, and coordinating quality control and quality assurance programs throughout the organization. The Director formulates regulatory, quality control and quality assurance policies and implements systems to ensure compliance with regulatory and accreditation standards and to promote the continuous improvement of design, production, and administrative practices.
What will make you successful (Minimum Requirements)
Bachelor’s degree in business, scientific, or related field is required
10+ years of quality and regulatory management experience in a regulated industry, in Tissue Banking
Must demonstrate strong understanding and knowledge of FDA and AATB requirements
Experience in bio-manufacturing operations, including clean room environments and aseptic technique is preferred
Certified Tissue Banking Specialist (CTBS) certification is preferred
What most days will include (Primary Duties)
Establish and enforce policies to ensure that PTT attains and maintains compliance with all FDA, OSHA, AATB, cGTP, and all other government regulations and accreditation requirements for the design, production, and packaging of human bone and tissue allografts for use in surgical implantation procedures.
Responsible for leading all regulatory activities for PTT to meet deliverables according to plan and regulations while working in conjunction with Production for product clearance, approval, or licensing and establishment registration and device listing.
Oversight of the PTT regulatory strategy which includes the development, implementation, and feedback on related regulatory activities for products planned for PTT in consultation with Research & Development. Lead the RAQA team to deliver on these expectations
Support documentation upon request for regulatory submissions (Pre-Submissions, 510(k)s, and License Applications) and Memos-to-File.
Assess and document the impact of proposed product changes with respect to regulatory submissions.
Manage the regulatory release of new products and addresses any import/export issues that arise.
Responsible for compliance review of product labeling, advertising, and promotional materials for PTT.
Maintain knowledge of the standards that apply to assigned products and/or projects and monitors any relevant development of new standards.
Identify critical points in work processes and specify sampling procedures to be used at these points.
Direct quality assurance reviews of donor charts and of all required forms and chart records.
Direct the collection and analysis of production and other work samples to evaluate quality.
Analyze quality test results and provide feedback and interpretation to management or staff.
Exercise authority to reject tissue or to stop production if deviations from standards warrant.
Direct the continuing review of quality systems processes and the formulation of new or revised procedures to reduce cost and/or enhance efficiency.
Communicate quality control and quality assessment information to management and to all relevant company departments, vendors, or contractors.
Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, and quality trends.
North Phoenix- near the 101 and 7th street
No- position is required to be onsite
Personal protective equipment provided or required
Social distancing guidelines in place
Sanitizing, disinfecting, or cleaning procedures in place
Pinnacle Transplant Technologies is a proud equal opportunity employer. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.
Employer will assist with relocation costs.
Additional Salary Information: * Comprehensive Health Benefits w/ Employer Cost Sharing
* Employer Sponsored Life and Disability Policies
* Generous Paid Time Off Program
* Ten (10) Paid Holidays Per Year
* 401(k) Profit Sharing Plan with 4% match; with NO vesting schedule
* Employee Assistance & Discount Program
Internal Number: RAQA01
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.