Senior Reg Affairs

CPL

Galway

Senior Regulatory Affairs Specialist. A senior Reg Affairs specialist position is available for my client in Galway. 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 Overview. 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. Helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. 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. Develops 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. Assist in the development of product reimbursement strategies. Lead applications for product reimbursements in line with company strategies. Provides Regulatory Affairs support during internal and external audits. Represents Regulatory Affairs on cross-functional project teams. Candidate Overview. Minimum education of degree in a technical field. Minimum 6 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. This job originally appeared on RecruitIreland.com.

1928 days ago