Role:The Senior Principal RA Specialist ( Medical Devices ) Management level role. Manage projects rather than team Location: Southampton area (Hybrid role ) 3 days in office Salary- ( on application ) Excellent package The Senior Principal RA Specialist is responsible for market access and maintenance of business regulatory activities for a designated sub-region within EMEA, which includes EU Countries, CIS, ACE, and MENA. This role supports the MDD/MDR, CIS, and ACE Country Regulations and heavily interacts with the EMEA Commercial leadership team. The This involves engaging as a trusted and strategic business partner, delivering pragmatic solutions and creative regulatory strategies to: Job Summary: The Senior Principal RA Specialist provides expert regulatory partnership and direction for products from concept to launch and post-market. This role involves leading the creation, development, and implementation of global/regional regulatory affairs procedures, ensuring compliance with regulatory requirements, and maintaining regulatory compliance status. The Senior Principal RA Specialist will also play a significant role in technical audits and regulatory intelligence processes. Essential Functions & Accountabilities: Regulatory Strategy and Leadership: Develop and execute regulatory strategies for assigned corporate projects. Provide expert regulatory guidance to project core teams and internal stakeholders. Lead the creation and implementation of regulatory affairs procedures for marketed products. Ensure compliance with global and regional regulatory requirements. Registration Activity: Review and approve regulatory documents for product registration in assigned markets. Maintain submission documents and agile databases to ensure prompt and accurate access to regulatory information. Coach and mentor junior team members on regulatory submissions. Monitoring and Compliance: Keep up-to-date with regional and national regulations, guidelines, and advisory documents. Communicate regulatory requirements and changes to management and business partners. Establish and leverage relationships with government, regulatory agencies, and trade associations. Product Labelling and Support: Review and approve product labelling and marketing materials. Support “Own Brand” and “Private label” customers and liaise with EU Competent Authorities. Provide input to Regulatory Affairs Impact Documents (RAIDS). Commercial Partnerships: Participate in Cluster and Country Leadership Teams. Collaborate with Global Packaging/Labelling Operations to ensure final product meets package labelling requirements for intended destinations. Interface with project team members to drive regulatory and corporate initiatives to completion. Oversee and communicate project status to key stakeholders throughout the business, including the legal manufacturer, QA, Global RA, R&D, and Commercial. Participate in project initiation discussions with Global Supply Chain and Global Packaging to ensure meeting business goals related to Europe/ACE. Travel Requirements : Up to 20% local or international travel to facilities, government agencies, customers, trade shows, or training courses. Qualifications Knowledge, Skills, and Abilities : Strong leadership attributes and ability to influence decision-makers. In-depth understanding of ISO 13485, MDSAP, MDD, MDR, and other relevant regulations. Excellent attention to detail, organizational, and technical writing skills. Proficient in MS Office applications and relational database systems. Ability to work effectively in multinational/multicultural environments. Strong communication skills and ability to manage multiple priorities. Experience : 8-12 years of experience in the regulated medical device industry. Extensive experience with regulatory submissions and technical documentation. Proven track record of managing complex regulatory projects and audits. Experience in electronic document management systems. Education: Bachelor’s degree in a scientific or technical discipline required. Advanced degree and Regulatory Affairs Certification highly desirable
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