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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Manpower CHLausanne et environ
Vor 30+ Tagen
Stellenbeschreibung

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.