Principal Regulatory Affairs Specialist(m/w/x)

As a Principal Regulatory Affairs Specialist, you will play a vital role in ensuring that product launches meet regulatory standards. Your day-to-day responsibilities will involve collaborating with various teams, overseeing submissions, and monitoring regulatory changes to support successful market entry.

Anforderungen

• •Bachelor’s degree in life sciences
• •7+ years of regulatory affairs experience in biotechnology or medical device industry
• •Proven experience supporting commercial launches across global markets
• •Strong understanding of regulatory frameworks and their commercial implications
• •Demonstrated ability to translate regulatory requirements into actionable business guidance
• •Exceptional leadership, communication, and cross-functional collaboration skills
• •Strategic thinker with a results-driven approach to regulatory problem-solving
• •Attention to detail and excellent communication skills
• •Ability to organize, plan and adjust work assignments while meeting deadlines
• •Familiarity with digital marketing regulations and social media guidance
• •Knowledge of Class II and/or Class III medical devices and combination products
• •Demonstrated ability to balance regulatory compliance with business objectives
• •Prior experience in a matrixed, fast-paced, or launch-phase organization