Senior Regulatory Affairs Specialist

For our client, a leading pharmaceutical firm, we are actively looking for a 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.