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 projection of future activity loads.
Develop, organize and maintain documentation to support all product marketing approvals, licenses, clearances, registrations and certifications.
Maintain Regulatory approval/clearance database for where products are cleared from a Regulatory perspective for distribution.
Analyze regulatory environment changes and strategically implement requirements within submission preparations as well as communicates 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, 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.
Provide senior level regulatory expertise consultation and training across the organization, including development of less tenured Regulatory team members.
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.
BS/BA Degree in relevant technical discipline (Engineering, Science or Medically related) required
5+ year relevant device or pharmaceutical regulatory experience
Knowledge of FDA medical device and/or tissue regulations, ISO standards and EC directives (934/42/EC) required
AATB CTBS, RAC-EU or US certifications a plus
Working knowledge of Microsoft Office Suite (e.g. Word, PowerPoint, and Excel) required
Strong leadership, interpersonal and organizational skills required.
Strong oral and written communication skills, including technical writing at a professional level required.
Ability to work with minimal supervision, set priorities, problem-solve and manage multiple projects required
Demonstrated ability to work in dynamic environment, work under pressure and meet due dates required
Demonstrated knowledge of domestic and international regulatory submissions required.
Ability to interpret and implement regulations and guidance documents required
RTI Surgical™ is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing fa...cilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of Advamed.