Direct message the job poster from Sigmar RecruitmentEngineering Executive Consultant | GalwaySenior Regulatory Affairs SpecialistAbout Your New Company:Our client is an expanding medical device company based in Galway. It is a pivotal time to join the business as it moves to a new chapter within medical device manufacturing.You will help to develop regulatory strategies, perform activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets.Specific emphasis on:Completing US FDA submissions.Extremely organisedAble to work with minimal supervisionKey Responsibilities:Maintain an excellent understanding of global medical device regulations, for specific jurisdictions, primarily in accordance with specific FDA guidance & MDD 93/42/EEC.Develop global regulatory strategies.Plan and prepare regulatory submissions with specific emphasis on US FDA, i.e. 510(k), HDE, IDE and PMA submissions.Communicate directly with regulatory authorities to ensure product approvals are achieved in a timely manner.Maintain registration information (license numbers, expiration dates etc) and obtains re‐registration approvals in advance of license expirations to ensure no disruption in product availability.Provide ongoing support to currently marketed products as necessary including input on change notifications, etc.Lead the Design Review process in compliance to internal procedures including EU and FDA requirements.Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records.Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC and FDA requirements.Lead risk management process and preparation of risk management files including Use and Design FMEAs as required.Skills, Qualifications & Experience:Minimum 5 years’ experience in Regulatory Affairs, Design Assurance or similar role in a medical device company.Primary and/or a postgraduate degree BS, MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.Working knowledge of FDA requirements including Quality System Regulation (21 CFR 820), the Medical Device Directive (93/42/EEC) and applicable harmonised standards and the ability to apply them in practice.Previous experience with submissions to US FDA is a distinct advantage.Seniority level: Mid-Senior levelEmployment type: Full-timeJob function: Engineering, Science, and ManufacturingIndustries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing
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