Support assigned regulatory submissions including registration strategy, timeline and submission coordination, development/review of documentation, submission tracking, and liaison with regulatory authorities. Support distributors and business partners in securing and maintaining regulatory clearances.
Support province tenders, as necessary, in a timely and effective manner
Collaborate with US and EU based Regulatory personnel.
International nature of the position requires at times flexibility in working hours (e.g., international travel and teleconferences).
Maintain systems for tracking current projects and projection of future activity loads
Develop, organize and maintain documentation to support product marketing approvals, licenses, clearances, registrations and certifications.
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 technical protocols/reports and other outputs of product development as appropriate.
Maintain data and provide the business with the information on evolving Asia regulatory legislation and participate in assessing impact of changes on company interest.
Provide consultation and training on regulatory and labeling matters to all applicable areas of the organization, including researching and providing information pertaining t go relevant market requirements.
Participate in audits and inspections by regulatory authorities and certification/accreditation bodies as necessary.
Maintain metrics on regulatory performance and participate in process improvement, departmental and cross-functional projects as assigned.
Other duties as assigned.
BS/BA Degree in relevant technical discipline (Engineering, Science or Medically related) required
1+ year relevant device or pharmaceutical regulatory experience required
Prior experience with China Food and Drug Administration (CFDA) medical device submissions and submission strategy
Knowledge of CFDA medical device regulations required, and ISO standards a plus
Regulatory Affairs Certifications a plus
Ability to communicate effectively through written and spoken English and Chinese required, including technical writing at a professional level
Working knowledge of Microsoft Office Suite (e.g. Word, PowerPoint, and Excel) required
Strong leadership, interpersonal and organizational skills required
Ability to interpret regulations and guidance documents and develop effective regulatory strategy 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
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.