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!
Position Overview
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.
Key Responsibilities
· 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.
Requirements
· 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.