About Us
Pinnacle Transplant Technologies is a multi-service tissue bank committed to honoring the gift of donation and improving patient’s quality of life through the processing and distribution of high-quality allograft implants. For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine.
Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).
How You Contribute to Pinnacle Transplant’s Success
The Regulatory Affairs Specialist shall provide Regulatory support to PTT Leadership and Project Teams, while assisting their direct Supervisor in maintaining communication on Regulatory Affairs topics to Customers as well as Regulatory Bodies and Accrediting Institutions. The Regulatory Affairs specialist will be responsible for the tracking and trending of metrics associated with the Regulatory Affairs Team, as well as maintenance of files, while also assisting their direct Supervisor with other organizational tasks as requested.
Work hours:
Monday – Friday, flexible hours (i.e. 8am – 5pm), in office
(NO RELOCATION PROVIDED)
Work environment:
Office Environment with some interaction within Manufacturing
Location:
North Phoenix, near 19th Avenue and Pinnacle Peak Road
Pay Rate:
$71,200 - $92,000, dependent on experience
What You Will Do
- Assist in the preparation and or review of routine regulatory applications and submissions such as establishment registrations, annual registrations, state license renewal, or other registrations as applicable.
- Assist in responding to, and fulfilling Customer requests for regulatory information, supporting their National and International submissions.
- Maintain regulatory files/database effectively, and in accordance with standards and best practices while maintaining inspection readiness.
- Establish and maintain systems for tracking documents submitted to agencies or partners.
- Investigate and respond to Customer Complaints in compliance with regulations, standards and PTT requirements.
- Assist in maintaining adverse event handling system; Provide support in product notification and recall activities should they occur.
- Provide periodic data/metrics reports and assemble information for Management Review.
- Review labeling, Instructions for Use, and other documentation for accuracy and compliance with regulations and standards.
- Provide ongoing support to product development teams for regulatory issues/questions.
- Other duties as assigned
What Qualifications You Will Bring
- Knowledge of regulations relevant to the tissue banking and/or medical device industry. Specific knowledge and experience with FDA, EU and other international regulations preferred.
- Knowledge and experience with AATB Standards or ISO 13485 preferred.
- Minimum of 3 years experience in a regulatory or regulatory support role preferably within the tissue banking industry.
- Quality audit support experience, Regulatory Inspection support experience preferred.
- A degree or certification in a relevant field of study with two years may be acceptable with relevant experience in tissue banking or medical device industry. 4 year degree is preferred.
How You Will Grow
- Develop knowledge of tissue banking
- Enhance skills in regulatory requirements that impact the acquisition, processing and distribution of donated human tissue and knowledge of future regulatory landscape.
Who You Will Partner With
- Your Supervisor. You will have daily verbal and written communication with your Supervisor to ensure goals are understood and executed with efficiency and quality.
- Your Team. Regularly work in independent and team settings maintaining professional communication with all PTT team members.
- External Parties. You may have direct interaction with Customers or other partners in order to fulfill requests or complete complaint investigations.
Where You Will Work
- Full Time position (40 hours or more). Hours may include evenings and weekends to perform tasks outlined in the job description on an as-needed basis
- Travel by personal auto, charter or commercial aircraft may be required with reimbursement for personal auto used provided by the company policy according to IRS policy
- You will work in an office environment in a manufacturing facility in North Phoenix , having periodic contact with human tissue and bone. You may be required to enter a cleanroom environment, where you will wear protective clothing including but not limited to hoods, face masks, gloves, boots, and coveralls.
- Position may have minimal travel at the discretion of your supervisor.
Benefits/Total Rewards
- Comprehensive medical, dental, and vision insurance, eligible first day of the month following your start date.
- Company-Paid Short and Long-term Disability Insurance.
- Company-Paid Identity Theft Protection.
- Company-Paid Life Insurance Policy of $50,000.
- 401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of employment, and 100% Vested from the start of plan.
- Additional benefits such as: Voluntary Life/AD&D, Accident, Critical Illness, Hospital, and Pet Insurance.
Paid Time Off:
- (4) weeks paid vacation, prorated based on quarter hired.
- (1) week, 40 hours of paid sick time. Accrual starts at date of hire per pay period. Use available after 90-days of employment.
- (10) annual paid holidays.
71200.00 To 92000.00 (USD) Annually
