Job Description

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we\xe2\x80\x99re committed to creating a world where every patient who should be monitored will be monitored with smart technology.If you\'re eager to contribute your expertise and commitment to Critical Care\xe2\x80\x99s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.Appendix:On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards\xe2\x80\x99 announcement about the acquisition can be found here:Key Responsibilities:

• Manage execution of SEA ANZ Regulatory Affairs inclusive of processes, procedures, operational standards and systemically driven controls that ensure regulatory compliance and deliver market access for SEA ANZ.

• Develop and plan regulatory affairs projects and strategy activities for product lifecycle management of new products, product changes and renewal submissions for product applications or country notifications in SEA ANZ, with responsibility for successful completion of all project deliverables within agreed timelines. Provide regulatory support for global product registration projects.

• Provide guidance to regulatory personnel, project teams and other cross functional partners for tactical project execution, issue identification/mitigation, and assistance on various related topics (e.g. clinical trials, standards, advertising, testing requirements, product launch, etc.) in SEA ANZ countries with a regulatory framework.

• Ensure review and approval of promotional materials to comply with local regulatory requirements; manage local clinical trial submissions and SAE reporting (adverse events); analyze information on product recalls from field corrective action team and provide reports to local governments.

• Analyze local regulatory trends and market intelligence information; advise and make recommendations to leadership on potential high impact risks and change implementation; manage creation of local regulatory affairs strategy.

• Build and maintain relationships with internal regulatory affairs and cross-functional partners, local regulatory authorities and national and regional trade associations as requested; may act as a point of contact for regulatory authorities.

• Identify and evaluate registration, labeling and build process improvements and course alignment/correction opportunities.

• Ensure proactive maintenance and compliant entry of local submissions, approvals, and license expiries in the established regulatory database system.

Required Education and Experience:
Bachelor\'s Degree plus 8 years of experience in Regulatory Affairs or related field OR
Master\'s Degree plus 6 years of experience in Regulatory Affairs or related field
Other: Experience working in a healthcare company, regulatory affairs and medical device
Ability to fluently read, write and speak EnglishAdditional Skills:

• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Word, Excel and government regulatory systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Fluent in reading, writing and speaking English
• Extensive knowledge of regulatory affairs within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of related aspects of product lifecycle processes and Critical Care Ignite system and government regulatory systems
• Extensive knowledge of Critical Care products
• Knowledge of healthcare industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with country management teams (e.g. Business Unit head, Quality head, Ops head, Finance head)
• Consult in project setting within specific sections of regulatory affairs area
• Provides leadership to outsourcing partners of regulatory affairs consulting companies (e.g. on registration, labeling) on special projects
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/contro

Edwards Lifesciences