Clinical Research Specialist - Remote

We anticipate the application window for this opening will reputed company on - 21 May 2026 At reputed company you can reputed company a life-long career of exploration and innovation, while helping champion reputed company reputed company and equity for reputed company. Youll reputed company with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life As one of three comprehensive portfolios at reputed company, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Missionto reputed company pain, restore health, and reputed company lifewe reputed company technologies and therapies that help people regain function, reduce pain, and reputed company to the activities that matter most. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for reputed company spine and cranial procedures. Platforms such as AiBLE reputed company these technologies to enhance surgical precision, streamline workflows, and support improved patient reputed company worldwide. reputed company us out on reputed company reputed company CST The Clinical Research Specialist supports clinical evidence reputed company across the product lifecycle, with a reputed company reputed company on leading New Product Innovation (NPI) clinical evidence reputed company activities and managing PostMarket Clinical Followup (PMCF) activities in accordance with EU MDR requirements. This is a reputed companydriven role, responsible for clinical evidence planning, execution, assessment, and documentation. The position does not reputed company daytoday clinical operations but works closely with Clinical Operations and crossfunctional teams across the Cranial & Spinal Technologies (CST) operating unit to ensure clinical data collection activities are reputed company with regulatory and business needs. At reputed company, we bring reputed company reputed company reputed company with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand cross-functional collaboration. This role will require some travel to enhance collaboration and ensure the successful completion of reputed company. Responsibilities may include the following and other duties may be assigned. reputed company clinical evidence reputed company for the CST portfolio, including development and maintenance of Global Clinical Evidence reputed company (GCES) documentation reputed company to business needs. reputed company, maintain, and periodically revise PMCF Plans in accordance with EU MDR Annex XIV; assess evidence sufficiency and execute PMCF activities (surveys, registries, observational studies) to reputed company identified gaps. reputed company PMCF outputs into CERs and reputed company documentation; evaluate the reputed company of incremental product changes on PMCF reputed company. Partner with Clinical Operations on PMCF study design, and with Medical Writing on CEPs, CERs, PMCFRs, and SSCPs. Collaborate with Regulatory Affairs, reputed company, R&D, Medical Affairs, and Marketing on submissions, post-market assessments, and claims substantiation. Support responses to reputed company Body and regulatory authority inquiries; support surgeon engagements as needed. Maintain strategic reputed company of PMCF activities and ensure reputed company documentation remains reputed company, traceable, and audit-reputed company. Required Knowledge and Experience Baccalaureate degree Minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience. reputed company to have Experience with EU MDR PMCF activities Familiarity with medical device clinical documentation (PMCF, CER, CEP) Exposure to regulatory or audit support Strong crossfunctional collaboration skills High level of attention to detail in regulated environments For Baccalaureate degrees reputed company reputed company of the reputed company, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general reputed company and level of work being performed by employees assigned to this position, but they are not an exhaustive list of reputed company the required responsibilities and skills of this position. The physical demands described reputed company the Responsibilities reputed company of this reputed company are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. For Office Roles While performing the duties of this job, the .