Regulatory Affairs Lead

Primary Function of Position:

The Regulatory Affairs Lead plays an important role in directing the regulatory team's efforts, focusing on New Product Development (NPD) and sustaining activities within designated Business Units. This role demands a deep understanding of regulatory compliance frameworks and strategic direction within the EU. The Regulatory Affairs Lead is responsible for ensuring the alignment of regulatory strategies with company objectives, leading to successful product launches and changes. The Regulatory Affairs Lead is central to fostering an environment of excellence and innovation, guiding the team through the regulatory landscape, and ensuring that products meet stringent regulatory standards.

Roles and Responsibilities:

Main activities

• Lead Regulatory Team efforts in support of NPD projects and sustaining operations within specified Business Units, acting as a primary point of contact for regulatory matters and ensuring regulatory compliance and strategic innovation.
• Develop and communicate comprehensive EU regulatory strategies for projects, guiding team members through the development and implementation process.
• Oversee the preparation and coordination of EU submissions for Medical Devices, securing timely regulatory clearances for new products, new indications, and product changes.
• Mentor team members in the creation and execution of CE Mark submissions and change notifications to our Notified Body (NB), including strategy development for responding to regulatory inquiries.
• Direct the preparation of CE Mark documentation for EU submissions related to NPD projects and product changes, ensuring thorough review before RA Management approval and NB submission.
• Ensure the completion and maintenance of Technical Documentation for CE Mark, adhering to regulatory requirements and best practices.
• Engage with Notified Bodies and Competent Authorities, representing the company's regulatory strategy and fostering positive relationships.
• Offer expert advice to cross-functional teams, interpreting and translating complex regulatory requirements into actionable strategies.
• Stay ahead of regulatory and standards changes, proactively updating company policies and procedures to maintain compliance.
• Initiate and lead process improvement projects to enhance the efficiency and effectiveness of regulatory procedures.
• Support the growth and skill development of team members, contributing significantly to the Regulatory Affairs department's continuous improvement.
• Provide performance review input for Regulatory Affairs Team members, acknowledging contributions and guiding professional development.

Additional activities

• Assists in the implementation and maintenance of the Quality Management System, such as CAPA, Management Review and audits
• Participates in internal/external audits and inspections, and ensures that company procedures, processes and documentation meet the requirements of the Quality Management System, ISO 13485 and other applicable regulations
• Provides regulatory support to other departments such as R&D, engineering and clinical affairs as needed
• Other regulatory tasks and projects may be assigned as necessary.