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).
RTI Surgical is a 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 & 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 judgment and holding 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 Greenville, N.C., and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
The Sr. Regulatory Affairs Specialist leverages their regulatory expertise to partner with internal and external stakeholders. The Sr. Regulatory Affairs Specialist can both support the direction of the Regulatory Leader and lead process improvement and regulatory projects with their own initiative.
Develop regulatory strategies and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
Manage regulatory submissions including registration strategy, timeline and submission coordination, development/review of documentation, submission tracking, and liaison with submitter/regulatory authorities. Support distributors and business partners in securing and maintaining regulatory clearances.
Maintain systems for tracking current projects and for projection of future activity loads.
Develop, organize and maintain documentation to support all product marketing approvals, licenses, clearances, registrations and certifications.
Maintain regulatory information for approved market authorizations
Analyze regulatory environment changes and strategically implement requirements within submission preparations as well as communicate changes effectively throughout the organization. Authors key portions of company responses to proposed standards, directives, policies and legislation regarding company products and systems.
Develop and maintain assigned departmental quality system procedures, and instructions and provide training as necessary both within and outside the department.
Coordinate regulatory aspects (e.g. design, development, review, approval, implementation, control, revision, translation) of the product labeling and promotional materials process, as needed, (e.g. package labels, ancillary labels, package insert, surgical technique, marketing materials) to assure accuracy, consistency and compliance with applicable State, Federal and International regulatory requirements, as well as company and customer requirements.
Provide regulatory support to product development and business teams. This includes preparation of regulatory opinion documents, coordination of labeling activities, as needed, and review /approval of design control documentation, risk management reports, technical protocols/reports and other outputs of product development as appropriate.
Support all aspects of the quality system, including participation in audits and inspections by regulatory authorities and certification/accreditation bodies.
Maintain metrics on regulatory performance and participate in process improvement, departmental and cross-functional projects as assigned.
Strong leadership, interpersonal, communication and organizational skills are required.
Ability to work with minimal supervision, set priorities, problem-solve and manage multiple projects preferred.
Demonstrated ability to work in dynamic environment, work under pressure and meet due dates required.
Bachelor’s degree (or non-US equivalent) in relevant technical discipline (Engineering, Science, or medically related) required.
5+ years relevant regulatory experience in medical device, pharmaceuticals or other medical products
Experience authoring and submitting medical device registration/ licenses required.
Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
General understanding of product development process and design control through knowledge of US FDA and international medical device regulations
Regulatory Affairs Certification (RAC) and AATB CTBS preferred.
A combination of education and experience may be considered
Light work: Physically handle objects up to 20 lbs. occasionally.
Office Setting - Open layout with assigned workstation or office