Senior Regulatory Specialist

4 weeks ago

Cork, Cork, Ireland Real Full time

Senior Regulatory Affairs Specialist (Contract) Position SummaryWe are seeking a dynamic and experienced Self-Employed/Freelance Senior Regulatory Affairs Specialist. This role is pivotal in ensuring our products and services adhere to all relevant regulations and standards. The successful candidate will collaborate with cross-functional teams to facilitate regulatory approvals, manage submissions, and maintain compliance with evolving regulatory requirements. If you are an enthusiastic self-starter with excellent organisational skills and the ability to balance immediate and long-term priorities, we want to hear from you.Key ResponsibilitiesRegulatory Strategy Development: Formulate and execute strategies for product registration, approval, and compliance.Daily Regulatory Management: Oversee day-to-day regulatory activities and manage multiple projects related to regulatory compliance.Submission Management: Prepare, maintain, review, and submit regulatory documents and applications to health authorities.Global Registration Support: Assist the team in obtaining and retaining country-specific regulatory registrations worldwide.MDSAP Implementation: Manage the implementation of the Medical Device Single Audit Program within the organization.Regulatory Compliance Monitoring: Ensure compliance with national and international regulatory requirements and quality standards.Risk Assessment: Identify and assess potential regulatory risks and propose effective mitigation strategies.Cross-Functional Collaboration: Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.Regulatory Updates: Stay current with changing regulations, guidelines, and industry trends.Quality Assurance Contribution: Maintain high-quality standards within the organization by assessing risk profiles and creating mitigation programs/tools.Post Market Surveillance: Manage activities including logging customer complaints and adverse events, coordinating investigations, and conducting regulatory trending and reporting.CE Mark Submissions: Handle submissions, significant change notifications, and interactions with Notified Bodies.International Filings: Support the team with the preparation of international regulatory filings, including 510(k) submissions and FDA correspondence.Material Review: Ensure public-facing materials comply with regulatory standards.Additional Duties: Perform other regulatory-related tasks as required.Essential Skills and Qualifications****Minimum of 8 years of regulatory experience in the medical device industry.**** Essentials:Educational Background: Bachelor's degree in Engineering or Science.Regulatory Knowledge: Thorough understanding of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CFR 820, and supporting standardsProven ability to manage projects to deadlines successfully.Experience working directly with regulatory agencies.Strong ability to manage critical projects as part of an interdisciplinary team.Excellent problem-solving and communication skills.Highly organized, detail-oriented, and self-motivated.Excellent oral and written communication skills.Ability to work effectively as part of a cross-functional team.Thrives in a fast-paced, entrepreneurial environment.Strong skills in technical documentation and report writing.Desirable:Certifications: Regulatory certifications in EU MDR and US FDA.Advanced Education: Master's degree in a relevant field.Please click to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real, please visit Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC(phone number removed) England and Wales

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