Work Flexibility: Hybrid or Onsite****12 months fixed term contract (Hybrid role)****Key Areas of Responsibility Provides regulatory affairs support to the Patient Specific Solutions business to achieve timely approvals of custom devices via custom and compassionate use pathways.Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutionsIdentifies requirements and potential obstacles for market access distribution.Assists in the development of regulatory strategy and updates strategy based upon regulatory changesEvaluates proposed products for regulatory classification and jurisdictionDetermines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activitiesNegotiates with regulatory authorities throughout the product lifecycleIdentifies the need for new regulatory procedures, SOPs, and participates in development and implementationHelps train stakeholders on current and new regulatory requirements to ensure organization-wide complianceAssists other departments in the development of SOPs to ensure regulatory complianceAdvises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulationsAssesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulationsProvides regulatory information and guidance for proposed product claims/labelingEnsures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claimsPrepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelinesMonitors the progress of the regulatory authority review process through appropriate communications with the agencyCommunicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication toolsWorks with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committeesEducation/Work ExperienceBS in Engineering, Science, or related or MSc in Regulatory Science or Clinical ScienceTypically a minimum of 4 years experienceRAC(s) preferredKnowledge/CompetenciesStrong project management, writing, coordination, and execution of regulatory itemsEmphasis on technical, clinical and scientific regulatory activitiesDemonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance and distributionUnder general supervision, plans, conducts and supervises assignmentsReviews progress and evaluates resultsRecommends changes in proceduresOperates with appreciable latitude for unreviewed action or decisionReviews progress with managementMay direct work of Specialist or Sr. SpecialistSeeks out diverse ideas, opinion, and insights and applies them in the workplaceConnects and relates well with people who think and act differently than oneselfEmbraces scrutiny and accepts feedback as opportunity to learn and improveChooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resourcesNavigates the dynamics, alliances, and competing requirements of the organization or businessWillingly accepts challenging assignments and new career opportunities that stretch and build capabilitiesTravel Percentage: 10%