Senior Regulatory Affairs Specialist

Key Responsibilities Core Activities: Lead regulatory activities for NPD projects and sustaining operations, including preparing, coordinating, and maintaining EU Medical Device dossiers, CE Mark submissions, and Technical Documentation, ensuring alignment with EU regulations. Serve as the primary liaison with Notified Bodies, presenting regulatory strategies, addressing inquiries, and ensuring compliance with applicable laws. Oversee the preparation, submission, and upkeep of EU Medical Device registration dossiers and other region-specific filings, ensuring timely approvals and adherence to business timelines. Develop and execute EU regulatory strategies for new product launches, product modifications, and expanded indications, ensuring compliance and alignment with business objectives. Offer regulatory guidance to cross-functional teams to ensure product development and modifications meet current regulatory standards. Stay informed about updates to global and EU medical device regulations and standards, ensuring internal policies and procedures reflect these changes. Collaborate with Sales and Marketing to align registration strategies with business goals. Participate in process improvement initiatives to optimize the efficiency of regulatory submissions and department workflows. Additional Responsibilities: Support and enhance the Quality Management System (QMS), including CAPA processes, Management Review activities, and internal/external audit participation, maintaining compliance with ISO 13485 and other applicable standards. Mentor junior team members, fostering their professional growth and enhancing departmental capabilities. Collaborate with R&D, engineering, and clinical affairs teams to support successful product development and lifecycle management. Respond to regulatory queries from internal stakeholders such as Customer Service, Sales, and Contract/Tender teams. Undertake additional regulatory tasks and projects as assigned to ensure compliance across all operational areas. Essential Skills and Experience: 8 years of regulatory affairs experience within the medical device industry, with a strong focus on EU regulations. Bachelor's or Master’s degree in Engineering, Medical Technology, or a related field (or equivalent practical experience). Comprehensive knowledge of global medical device regulations, including ISO 13485, European Medical Device Directive (93/42/EEC), and EU Medical Device Regulation (2017/745/EU). Proven track record in managing EU submissions for NPD projects, CE Mark documentation, and Notified Body interactions. Strong leadership, organizational, and interpersonal skills, with a proactive, problem-solving mindset and ability to work effectively in international, cross-functional teams. High attention to detail and accuracy in all aspects of work. Familiarity with EU regulations like RED, ROHS, and the Waste Framework Directive. Proficiency in English (C1 level minimum) and advanced computer skills, including Microsoft Office Suite. Preferred Skills and Experience: Experience with Class III medical devices under the EU Medical Device Regulation, including CE Marking. Knowledge of US FDA regulations (21 CFR 820.30) and experience with 510(k) submissions. Background in project management or leadership roles in regulatory affairs or product development. For our client, a leading pharmaceutical firm, we are actively looking for a Senior Regulatory Affairs Specialist.

Location: le-mont-sur-lausanne, CH

Posted Date: 11/20/2024