What are the responsibilities and job description for the Regulatory Specialist position at RTI Surgical Inc?
Job Title: Regulatory Specialist
Department: Regulatory
Effective Date: 06/01/2022
Location: Alachua, FL; Remote
While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
SUMMARY:
RTI Surgical is global, industry-leading private label OEM with expertise in allograft, xenograft and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.
As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic and reconstructive surgery, urology/urogynecology and trauma.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values:
We are accountable to each other by trusting each other’s judgement and hold each other responsible for results.
We find joy by striving to create a working environment that people enjoy.
We fully engage by focusing our hearts and minds on our customers, patients, and each other.
We adapt to change by working collaboratively to be flexible to the changing needs of our business.
RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in the Greenville, N.C. and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and have supported the transformation of the company to its next level of potential.
POSITION SUMMARY:
This position will be responsible for analyzing and supporting/resolving functional business issues and needs, as well as meeting assigned performance objectives, completing assigned tasks, and achieving set metrics in area of specialization. The Specialist will ensure adherence to company policy and procedures, and will assist in maintaining quality control processes throughout RTI Surgical. This position will help RTI Surgical maximize the amount of patients served while maintaining a high level of quality and safety through the support of the business functions.
RESPONSIBILITIES:
Provide regulatory support to product development teams. This includes preparation of regulatory opinion documents, coordination of labeling activities and review /approval of design control documentation, risk management reports, technical protocols/reports and other outputs of product development as appropriate.
Develops and reviews labeling, advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Responsible for supporting assigned department or function while acting as a liaison to internal and external customers
Maintain awareness of global regulatory changes and leads impact assessment of changes.
Participates and assists in internal and external requests. Assists in immediate action and correction of operational and customer services issues and complaints
Responsible for ensuring assigned metrics are maintained; which may also include preparing, tracking, and trending reports, conducting audits and providing timely feedback to stakeholders
Develop and maintain effective working relationships with RTI management team and staff to support needs of the business and ensure requested information is obtained timely, is complete and accurate
Support company and departmental quality and business objectives and initiatives
Other duties as assigned
CORE COMPETENCIES:
Strong writing, communication, and interpersonal skills
Strong attention to detail; ability to multi-task and balance competing priorities
Knowledge of FDA, EU, and other regulatory body regulations
EDUCATION/EXPERIENCE REQUIRED:
Bachelor’s degree (or non-US equivalent) in relevant technical discipline (Engineering, Science, or medically related) required.
3 years relevant medical device or pharmaceutical regulatory experience
Regulatory Affairs Certification (RAC) and AATB CTBS preferred.
A combination of education and experience may be considered
Physical Requirements:
Light work: Physically handle objects up to 20 lbs. occasionally.
Work Environment:
Office Setting - Open layout with assigned work station or office
