Regulatory Affairs Specialist - Invitro Diagnostics

• Identifies information sources and resources for SFDA's regulations.
• Collects and coordinates information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.
• Assist in device registration activities - SFDA communication; registration requirements; participation in submission document preparation.
• Maintain files on local, regional, and global regulatory intelligence and other related information.
• Track the status of applications under regulatory review and provide updates.
• Helps prepare technical documentation, pre-market authorization applications and change notifications.
• Generate regulatory reports to communicate local registration activities.
• Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives.
• Collaborate with regulatory leaders and peers to expedite approval of new and ongoing registrations.
• Provide training and coordinate with department personnel from regulatory, quality, and manufacturing sites, Sales, and Marketing.
• Organizes and maintain RA files such as Responsibilities Matrix, Certificates from Notified Bodies, and other RA related archives. Ensures that existing approvals and documentation are maintained.

• Good organizational skills with attention to detail and accuracy.
• Ability to work independently in a fast-paced environment with flexibility to manage changing priorities.
• Interprets subjective and intricate aspects of specific regulations and has detailed understanding of multiple sets of associated regulations.
• Able to confidently deal with ambiguous issues and provide input towards suitable actions.
• Demonstrated excellence in communicating and presenting complex information to technical and non-technical partners.
• Proven ability to manage and prioritize multiple projects. Highly motivated, takes initiative, follow through, and complete projects in a professional and timely manner.
• IVD product registration experience is highly preferred.
• Understands Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products.
• Excellent oral and written communication and presentation skills. Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.
• Bachelor’s degree with 5 years of related work experience.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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