Senior Manager, Medical Devices

This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversee and execute regulatory and quality client projects pertaining to medical devices, in vitro diagnostics (IVD), and combination products.

• Cultivate and manage key client relationships, acting as the representative for clients in discussions with Health Authorities and/or Notified Bodies.

• Ensure that projects meet predefined KPIs, timelines, and budgetary constraints.

• Prepare, review, and assemble high-quality regulatory and quality documentation to support medtech initiatives.

• Offer daily operational support and consultancy to clients regarding medtech intelligence, evolving requirements, and best practices.

• Engage in regulatory, technical, and quality management processes for clients in the pharmaceutical, medical device, and diagnostics sectors.

• Interact with clients and Health Authorities/Notified Bodies; assist with scientific advice procedures and represent clients in authority interactions as necessary.

• Conduct seminars/lectures for colleagues, clients, and professional audiences; contribute to the sharing of departmental expertise and knowledge.

• Aid in the implementation of company strategy and continuous improvement efforts; ensure compliance with and assist in optimizing internal processes.

⛳️ Requirements

• A degree in Science, Medicine, Law, Engineering, or a relevant field.

• Extensive hands-on experience in regulatory affairs and quality management within the medical device and diagnostics (including IVD) sectors.

• Robust analytical and critical-thinking abilities, demonstrated by a history of independently and pragmatically resolving complex issues.

• Proven project management skills encompassing planning, execution, risk/issue management, and timely delivery to quality standards; experience in leading change management initiatives is a plus.

• Strong stakeholder management skills at the department-head level; exceptional written and verbal communication and presentation capabilities.

• Proficiency in business-level English and the local language.

• Experience with Companion Diagnostics (CDx) and/or combination products is desirable.

🏝️ Benefits

• A competitive compensation and benefits package tailored to experience and location.

• A senior, highly visible position focused on significant client delivery in the medtech field.

• The chance to engage in a diverse array of medical device, IVD, and combination product programs with leading organizations.

• A collaborative, expert-driven environment that fosters knowledge sharing, influences best practices, and promotes continuous improvement.

• Opportunities for professional development to enhance your regulatory/quality expertise and leadership skills.