Melio Life Science are partnered with leading medical device company based in Minnesota. Specialising in cardiology, they have a team of eight regulatory professionals within the organisation and are seeking an experienced Director Regulatory Affairs to join their dynamic team!
As the Director of Regulatory Affairs, you will play a crucial role in ensuring compliance with regulatory requirements for their medical devices. The ideal candidate will have a strong background in 510(k) submissions, extensive experience managing regulatory affairs teams, and a deep understanding of ISO 13485 standards. This position requires effective collaboration with cross-functional teams to support product development, registration, and market access.
· Oversee and lead the preparation, submission, and maintenance of 510(k) submissions for new products and modifications.
· Ensure timely and accurate compilation of documentation in accordance with FDA regulations.
· Manage and mentor a team of 6 regulatory affairs professionals, fostering a collaborative and high-performance work environment.
· Provide leadership and guidance in the interpretation and application of regulatory requirements.
· Collaborate with R&D, Quality Assurance, Clinical Affairs, and other departments to integrate regulatory considerations into product development activities.
· Facilitate communication between regulatory affairs and other functional areas to ensure alignment on regulatory strategies.
· Maintain and enhance the company's compliance with ISO 13485 standards.
· Drive continuous improvement initiatives related to quality management systems.
· Develop and implement regulatory strategies to ensure timely market access for new products.
· Stay abreast of changes in regulatory requirements and proactively communicate implications to the organization.
· Monitor and analyze regulatory trends, guidelines, and precedents that may impact the company.
· Provide strategic input to senior management based on regulatory intelligence.
· Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
· 8+ years of experience in regulatory affairs within the medical device industry.
· Proven experience managing a regulatory affairs team of at least four members.
· In-depth knowledge of 510(k) submissions and FDA regulations.
· Strong understanding of ISO 13485 standards.
· Excellent communication and interpersonal skills.
· Ability to thrive in a dynamic, fast-paced environment.