Specialist, Clinical Science

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.

How youll make an impact

• Support and take some parts of development of accurate and effective clinical studies associated documents and study registration based on leader/manager directions.
• Develop and prepare some parts of clinical reports and associated documentation for successful completion within scope of project deliverables
• Support management of processes to obtain evaluate and resolve cross-functional input for document finalization for one BU product
• Serve as regulatory and clinical science liaison throughout product lifecycle. Participates in regulatory strategy and clinical science.
• Prepare clinical trial associated documents and evaluation report applications according to government regulations hospital ethics committee needs and company requirements for submission.
• Other incidental duties

What youll need (Required):

Bachelors Degree in related field 3 Years experience previous related experience Required or Bachelors degree in scientific discipline (e.g. Biology Microbiology Chemistry) Experience in preparing domestic and international product submissions Preferred

What else we look for (Preferred):

• Proven expertise in MS Office Suite including Adobe and ability to operate general office
• machinery
• Written and verbal communication skills including negotiating and relationship management skills
• Problem-solving and critical thinking skills
• Excellent ability to read write and speak English
• Full knowledge and understanding of Edwards policies procedures and global and China medical device regulatory guidelines relevant to clinical protocols
• Understanding of regulatory submissions reporting and audits
• Problem-solving and organizational skills
• Ability to manage confidential information with discretion
• Must be able to work in a team environment including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often
• Requiring coordination between organizations 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