Director, Medical Device Program Lead

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

📋 Description

• Serve as the backup for the head of the device team.

• Suggest cross-functional activities that foster innovation, strategic partnerships, and ongoing improvements.

• Lead collaborative efforts to establish targeted device profiles.

• Create project plans and budgets for device development in conjunction with both internal and external cross-functional teams.

• Ensure the delivery of high-quality products and processes, complete with the necessary validation and regulatory documentation.

• Produce device history files (DHF) that comply with FDA 21 CFR Parts 820 and 4, ISO 13485, EMA, and NbO regulations.

• Collaborate with the Regulatory Team to draft submission dossiers for FDA and NbO (EMA).

• Engage in the rapid response team addressing device-related inquiries and requirements from Health Authorities.

• Monitor and report on device development timelines, budgets, and risks; escalate concerns to management as needed.

• Act as a liaison between biosimilars project development teams, medical device sub-teams, and device vendors.

• Provide both technical and business insights, assess risks, and propose mitigation strategies.

• Supervise activities related to device development, manufacturing, validation, and regulatory compliance.

• Proactively identify and alert stakeholders to potential risk areas.

• Discover new device opportunities.

• Spearhead innovation and continuous improvement initiatives.

• Assist in managing the lifecycle of marketed products, including handling complaint investigations, change controls, and DHF updates.

• Support the development of labeling in collaboration with Human Factors Engineering (HFE), Regulatory, and Marketing for HFE validation activities.

⛳️ Requirements

• Bachelor’s degree (or equivalent) in a relevant field such as Product Design, Mechanical Engineering, Process Engineering, Materials Science, or Electronic Engineering.

• Over 5 years of project management experience.

• More than 10 years of experience in device development, with a solid grasp of device safety, regulatory requirements, policies, and procedures.

• Experience with FDA-regulated medical devices, standalone CE-marked devices, and combination drug-device products.

• In-depth technical knowledge of device design, validation, and verification, along with their connections to drug CMC, clinical, manufacturing, regulatory, quality, and commercial functions.

• Proven ability to resolve issues within a matrix organization.

• Excellent interpersonal and relationship-building abilities.

• Strong organizational skills, meticulous attention to detail, and effective multitasking capabilities.

• Proficient in both verbal and written communication.

• Fluent in English, both spoken and written.

• Proficiency in additional languages (German or French) is a valuable asset.

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Collaborative work environment promoting innovation and teamwork.