Regulatory Affairs

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

Roles & Responsibilities

• Responsible for planning and liaising with stakeholders to lead the implementation of various regulatory process improvement projects and work directly with key stakeholders in all business units as well as Edwards’ JAPAC counterparts to accelerate market access routes and ensure compliance
• Monitoring regional regulatory changes and collaborate with regulatory intelligent team, In-country RA team to help identify and follow up the execution to meet the requirements and ensure all regulatory SOP compliance with new requirements.
• Point of contact and support for RA team for regulatory systems and databases.
• Propose strategies and contingency planning with respect to JAPAC regulatory requirements, including assessing the impact of proposed and current regulations and proposing solutions for expediting approvals.
• Facilitate and/or lead teleconference and in-person meetings with key stakeholders including international partners
• Effectively execute and provide recommendations on process improvement/remediation projects to expedite new product launches based on prior experience and responses from regional and international affiliates
• Provide support to supervisor as needed

Requirements

• Bachelor’s degree with 3-5+ years medical device, or bio-tech or pharmaceutical industry
• Strong project management, problem solving and organizational skills
• Ability to speak, read and write English fluently and reading/ speaking Japanese is a plus.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive understanding and knowledge of principles, theories, and concepts relevant to managing complex project plans
• Excellent problem-solving, organizational, analytical, and critical thinking skills
• Strong leadership skills and ability to influence change
• Experience in facilitating change, including collaboration with management and functional stakeholders
• Experience within a regulated environment
• Strict attention to detail
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including serving as consultant to management
• Ability to travel up to 20% of time within Asia pacific countries and global manufacturing site/and Irvine especially in early phases of process design and implementation