Manager RA Operation - JAPAC

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

1. 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.
2. Monitor regional regulatory changes and collaborate with the regulatory intelligence team and In-country RA team to help identify and follow up on the execution to meet the requirements and ensure all regulatory SOP compliance with new requirements.
3. Act as a point of contact and support for the RA team for regulatory systems and databases.
4. 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.
5. Facilitate and/or lead teleconferences and in-person meetings with key stakeholders, including international partners.
6. 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.
7. Provide support to supervisor as needed.

Requirements

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