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We're looking for a Senior Regulatory Affairs Specialist for a fast growing med tech company based Cork (Ireland). The successful candidate will collaborate with cross-functional teams to facilitate regulatory approvals, manage submissions, and maintain compliance with evolving regulatory requirements. This position offers an excellent compensation package and potentially hybrid working. Responsibilities Regulatory 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 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 Skills and Qualifications Bachelor's degree in Engineering or Science or practical expertise Regulatory experience in the medical device industry Understanding of ISO 13485, ISO 14971, EU MDR, UK, MDSAP, 21 CFR 820, and supporting standards Please visit our website 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 our website 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 | OC387148 England and Wales

This is a fantastic opportunity for a Senior SAP HCM/Payroll Consultant to join one of the world's top 10 IT service providers delivering solutions to more than 9,000 customers worldwide. .* Candidates must be able to work in the UK without restrictions.* The Role at a Glance: Senior SAP HCM/Payroll Consultant UK Remote/Occasional Visits to Office and Client Sites as Required Up to £75,000 Plus Full Benefits Package Permanent - Full Time Reporting to: HCM Practice Lead Product/Service: Global authority in Enterprise SAP Consulting & SAP Managed Services Values: Clients First, Foresight and Teamwork Who we are: We are a global SAP Platinum Partner with over 9,000 SAP experts across 29 countries. We have a range of businesses, including multinationals and very large household names in our portfolio, across many industries and countries. We have a large number of consultants, UK wide, who provide support across all SAP areas as their primary job function. We take care of our customers' solutions from A to Z, transforming trust into value. From analysing and optimising customer processes, to implementing tailored solutions to suit their needs, to service and maintenance of their SAP system landscape. We work collaboratively with our own teams, the project delivery teams and our customers to ensure long term support excellence and vision. The Opportunity: As Senior SAP HCM Payroll Consultant, you will be responsible for delivering customer work across the Managed Services customer base. This dynamic role involves a variety of tasks, including ad-hoc configuration changes, process improvement recommendations, support for annual payroll patching in the UK and Ireland, and engaging in mini projects. You will be a team player who excels at building trust and strong connections with customers. Additionally, you will provide solution recommendations and collaborate closely with a team of highly skilled SAP HCM/Payroll Consultants. About you: Essential: Functional/technical proficiency with at least 8 years SAP payroll experience Excellent general SAP payroll knowledge - design, configuration and testing of core payroll functions from wage type creation to complex schema changes Specialist in UK and IE payroll processes with specific knowledge of Public Sector solution Knowledge of SAP HCM modules Personnel Administration and Time Management (negative and positive) Able to recommend process improvement options with confidence and expertise Experience of working in a SAP support background Excellent communications skills at all levels User support, problem solving, logical thinking and analytical skills Documentation skills such as functional specifications, test scripts and end user training End to end change management skills from requirements gathering, analysis, design, testing and implementation Able to multi task several pieces of work and follow change management processes Enjoys working independently and as a team player Can-do attitude Desirable: Knowledge of Success Factors integrations for EC to SAP ERP Certified in one Success Factors module ABAP Skills Join us to start the journey that is your career path. Career opportunities exist along multiple route maps from people and leadership, products and expertise and project management. Which route you take is up to you and we are on hand to provide guidance and support. We are an equal opportunities employer. You must be eligible to work in the UK and prepared to undergo high level security clearance Sounds like a good fit? Apply here for a fast-track path to the Hiring Manager Application notice We take your privacy seriously. When you apply, we shall process your details and pass your application to our client for review for this vacancy only. As you might expect you may be contacted by email, text or telephone. Your data is processed on the basis of our legitimate interests in fulfilling the recruitment process. Please refer to our Data Privacy Policy & Notice on our website for further details. If you have any pre-application questions please contact us first quoting the job title & ref. Good luck, Team RR.

Leading edge multinational organisation requires an in-house Senior Recruiter/Talent Acquisition Specialist to work on site on their R&D facility, due to growth in the business and need to expand the recruitment team. The site is involved in Technology and Manufacturing, ideally candidates will have experience in Semiconductors or other relevant R&D permanent recruitment. Candidates must have client side experience of "Workday" package (ideally the Recruiter module), and be experience at using "LinkedIn Recruiter" to hunt for talent (the LinkedIn account licence is provided by client) It is essential that the contractor will be self starting, and be able to use own initiative well, to develop strategies to manage the recruitment process for their roles. This role will be 6 months initially, but intention is to extend long term for the right candidate. The role must work on site and inside IR35. (We can assist with Umbrella companies if required) Please send CV for more details, interview and start ASAP. WA Consultants is an Employment Business and an Employment Agency as described within The Conduct of Employment Agencies and Employment Businesses Regulations 2003.