MedTech Regulatory Information Specialist

The IQVIA Connected Regulatory Intelligence (CRI) is a groundbreaking innovative solution that simplifies, integrates, and automates end-to-end regulatory processes that are essential for industry clients in meeting their global quality, regulatory and safety compliance obligations.  CRI provides the pharmaceutical and medical device industries easy access to original and translated regulatory documents, summarized regulatory intelligence and comparative tables with up-to-date key regulatory requirements worldwide.  As we look to develop our regulatory offering further, this role is to be part of the team designing for the future of Regulatory Intelligence.

Principal Accountabilities

• Authoring high quality regulatory content to aid in regulatory affairs submissions and facilitate the application of regulatory strategies
• Real time monitoring and analysis of changes in the regulatory landscape for an assigned set of countries and maintenance of the database accordingly
• Prepares regulatory documentation in area of content as per project schedules
• Depending on experience, gives guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
• Liaising with internal and external stakeholders to provide expert support

Essential Experience

• Qualifications in life sciences or related discipline
• Experience in MedTech regulatory submissions e.g.,
  • Developing regulatory strategy for design, development, V&V, manufacturing, and production controls for global releases of medical devices or IVDs
  • Change management
  • New product registrations
• Possesses at least 2-3 years of relevant regulatory affairs experience and/or technical expertise preferably in consultancy preparing application dossiers

Technical Skills

• Experience & knowledge of various databases (public/proprietary)
• Proficient in MS Office – Excel, Word, PowerPoint

Personal Skills

• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.
• Demonstrates self-motivation and enthusiasm; desire to learn new concepts and skills
• Excellent communication (verbal/written) skills
• Strong attention to detail
• Strong interpersonal skills and ability to interact at all levels within IQVIA
• Flexibility (should be ready to take additional responsibility as and when required)
• Ability to solve problems quickly and logically
• Team player and ability to collaborate at all levels but also able to work under own initiative
• Adept time and project management

The opportunity:

You will be working on a groundbreaking innovative solution and directly impact patient health through transforming client operations that bring safe and effective medical product to global markets in optimized timelines.  

We are a diverse, global team that shares a passion for collaboration and solving problems using best functional expertise and most advanced technologies to transform how regulatory teams do their daily jobs. Together, we will make a difference. 

Unleash Your Potential.

It takes brave minds to bring powerful ideas to reality.   

Join IQVIA and see where your skills can take you. 

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