Senior Regulatory Affairs Manager

You will own the Regulatory area at Powerful Medical. You will ensure proper compliance and alignment with regulatory standards for our already certified products and lead the certification of new ones. For this important role, we are looking for a seasoned professional, experienced with both MDR and FDA, who wants to impact one of the most important shifts in modern medicine.

Your role

• Lead the regulatory strategy of our innovative medical devices

• Own general project management of our regulatory agenda

• Manage, and prepare critical regulatory submissions

• Develop and lead QMS processes on regulatory affairs topics

• Manage our external regulatory consultants

• Own communication with regulatory bodies, incl. FDA and EU Notified Body

• Oversee the preparation of all necessary reports within the post-marketing surveillance activities

• Monitor and analyze changes in regulations and ensure their effective implementation across departments

Your profile

• 5+ years of experience in regulatory affairs and quality management

• In-depth knowledge of the US FDA and EU MDR regulatory landscape

• Experience with Software as a Medical Device and its regulatory implications with regard to software development, risk management, human factors engineering, and device architecture topics

• Successfully led regulatory submissions under FDA and EU MDR

• Excellent project management skills

• Experience in growing and managing high-performing and multi-disciplinary teams

• Display, encourage, and inspire a culture of excellence across the entire organization

Nice to have

• Knowledge of MDSAP and International regulatory experience in other leading markets, such as Australia, Canada, Japan, or Brazil

• Experience with AI/ML-based medical devices

• Experience with cardiology medical devices