Senior Regulatory Affairs Specialist

CardioFocus AG seeks a Senior Regulatory Affairs Specialist to lead regulatory strategies for invasive medical devices, ensuring global compliance and supporting R&D and manufacturing projects.

This position requires a professional who is both collaborative and technically empowered, with deep knowledge of global regulatory frameworks and integration solutions. The role demands expanded technical expertise in engineering aspects specific to invasive medical devices, including software, hardware, and materials science.

Responsibilities

• Foster regulatory and technical cooperation across various R&D and manufacturing initiatives.
• Create and implement regulatory plans for key clinical studies and product commercialization.
• Manage global submission processes independently.
• Design data collection protocols, compile documentation, and draft technical responses for audits and regulatory filings.
• Gather and structure diverse information to build regulatory strategies, guide organizational decisions, and predict future regulatory demands.
• Assist international partners with their regulatory submission activities.
• Manage workload priorities, optimize time usage, plan for resource needs, set objectives, coordinate team tasks, and develop practical action plans.
• Evaluate sales literature and promotional content for compliance.

Requirements

• Proficiency in technical communication.
• Advanced skills in the MS Office Suite and Adobe Pro.
• Proven leadership capabilities and the ability to translate regulatory mandates into clear directives for the organization.
• Strong writing skills, including the ability to edit for accuracy, adapt style to audience needs, present numerical data clearly, and interpret complex written information.
• Basic technical aptitude to process intricate technical, clinical, and test data, converting it into clear and concise regulatory submissions.

Nice to have

• Experience with Class III devices, particularly in electrophysiology or cardiology.
• Familiarity with the culture of small, dynamic companies.
• Background in clinical operations.
• Knowledge of IEC standards, biocompatibility, and sterilization processes.
• Experience with PMDA (Japan) regulations.

About the company

CardioFocus AG operates within a dynamic, fast-paced environment focused on delivering multiple projects simultaneously.

• Dynamic, fast-paced work environment.
• Focus on multi-project delivery.