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Senior Staff Regulatory Affairs Specialist
5 months ago
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World’s Best Workplaces, apply now
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team:
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Staff Regulatory Affairs Specialist to support our ENT Division. The role is based in Cork , Ireland.
Who we want:
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.What you will do:
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (, concept, development, manufacturing, marketing) to ensure product complianceAnticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutionsIdentifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)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 activitiesProvides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomesNegotiates 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 complianceProvides regulatory input and technical guidance on global regulatory requirements to product development teamsAdvises 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 regulationsEvaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissionsProvides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationshipsIdentifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research processProvides 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 committeesWhat you need:
BS in Engineering, Science, or related or MS in Regulatory ScienceTypically a minimum of 7 years experienceRAC(s) preferredDemonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation and compliance .Operates with appreciable latitude for unreviewed action or decisionSeeks 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 capabilitiesAbout StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at
