Taipei, Taiwan
24 days ago
Assoc Spec, Regulatory Affairs, Critical Care

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’re 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’s 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’ announcement about the acquisition can be found here:

https://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bd

Completes and maintains regulatory approvals and clearances of assigned products.

Key Responsibilities:
• Gather documents to assist with submission preparation dossier compilation in collaboration with senior RA team member.
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
• Assist in the gathering of information and research required by RA team.
• Assist in the gathering of information and research used to provide guidance and feedback to team on registration requirements for new and renewal registrations, product and process changes.
• Other incidental duties assigned by Leadership

Education and Experience:
Bachelor's Degree in related field, 1 year years experience previous related experience Required or
Other: in Scientific discipline (e.g., medical, pharma, Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Preferred
Other: Coursework, seminars, and/or other formal government and/or trade association training Preferred

Additional Skills:
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Good knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Goood knowledge and understanding of global regulatory requirements for new products or product changes
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• 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/control
 

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