Staff Regulatory Affairs Specialist page is loaded## Staff Regulatory Affairs Specialistlocations: Cork, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R******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 solutions* Identifies requirements and potential obstacles for market access distribution.
* Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Evaluates proposed products for regulatory classification and jurisdiction* Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities* Negotiates with regulatory authorities throughout the product lifecycle* Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation* Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance* Assists other departments in the development of SOPs to ensure regulatory compliance* Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations* Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations* Provides regulatory information and guidance for proposed product claims/labeling* Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims* Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines* Monitors the progress of the regulatory authority review process through appropriate communications with the agency* Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools* Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees**Education/Work Experience*** BS in Engineering, Science, or related or MSc in Regulatory Science or Clinical Science* Typically a minimum of 4 years experience* RAC(s) preferred**Knowledge/Competencies*** Strong project management, writing, coordination, and execution of regulatory items* Emphasis on technical, clinical and scientific regulatory activities* Demonstrate 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 distribution* Under general supervision, plans, conducts and supervises assignments* Reviews progress and evaluates results* Recommends changes in procedures* Operates with appreciable latitude for unreviewed action or decision* Reviews progress with management* May direct work of Specialist or Sr.
Specialist* Seeks out diverse ideas, opinion, and insights and applies them in the workplace* Connects and relates well with people who think and act differently than oneself* Embraces scrutiny and accepts feedback as opportunity to learn and improve* Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources* Navigates the dynamics, alliances, and competing requirements of the organization or business* Willingly accepts challenging assignments and new career opportunities that stretch and build capabilitiesTravel Percentage: 10%
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