Regulatory Affairs Specialist - EU Mdr Support

CPL

Galway

Regulatory Affairs Specialist – EU MDR Support.   The Regulatory Affairs Specialist provides independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches. Job Responsibilities. Lead the cross site technical file preparation for the MDR conversion of the product range and provide MDR guidance to the other cross functional teams. Helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials. The role assists in the development of best practices for Regulatory Affairs processes. Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (e.g. represents Regulatory in the complaint handling and field action process. Clearly defines and prioritises decision criteria, considers the benefits and risks of each solution before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision. Supports the development of labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations is required. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Provides regulatory advice to project teams. Guides conformance with applicable regulations in product development, support of claims and label content. Defines data and information needed for regulatory approvals. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Provides Regulatory Affairs support during internal and external audits. Represents Regulatory Affairs on cross-functional project teams. Candidate Requirements. Minimum education of degree in a technical field. Minimum 3 years’ experience in the medical device industry, with at least 3 years in a position in regulatory affairs or related/equivalent field. Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function. Experience of inspection by an external agency, such as the FDA. Ability to work well under deadlines and pressure. Demonstrated track record in: o             Submission of licenses and authorizations for the maintenance of existing products. o             International registrations and dossiers. o             Execution of regulatory strategies that align with business deliverables. For an immediate interview please forward your CV using the apply button. Or call Megan Warr on 091507515 for a confidential conversation.  .

1242 days ago