Boudicca® DX is a team of precision medicine experts providing on-demand regulatory support to accelerate the journey of healthcare products from concept to global approval. Known for operating with speed, efficiency, and expertise, Boudicca® DX partners with clients to streamline complex processes in the healthcare industry. The company specializes in delivering tailored solutions that support innovation and compliance. With a strong emphasis on flexibility and quality, Boudicca® DX helps bring life-changing products to market.
Role Description
Our experts guide clients through the complex landscape of global regulatory requirements, ensuring that every product—from clinical biomarker trial assays to AI-enabled medical devices—meets the highest standards of safety, performance, and clinical value.
LTANTS WITH EU AND US EXPERIENCE
Qualifications
Experience and knowledge in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
Proficiency in managing Regulatory Submissions and ensuring adherence to relevant standards
Skills in Project Management, including the ability to lead projects and meet deadlines effectively
Strong problem-solving and analytical abilities
Ability to work collaboratively in a hybrid environment
Excellent communication and organizational skills
Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related field
Experience in the precision medicine or healthcare product industry is a strong advantage
#J-18808-Ljbffr