As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day.

Our quality and regulatory affairs teams are responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence strategic and operational plans.

As our Regulatory Affairs Specialist, you will support and manage regulatory activities for Hologic Diagenode. From providing expert guidance during product development to preparing and submitting regulatory dossiers, you’ll be instrumental in ensuring our products meet both domestic and international compliance standards.

What To Expect

Act as the regulatory representative in product development teams, offering guidance on global regulatory requirements. Develop and execute regulatory strategies for domestic and international submissions. Provide input on product design, labeling, clinical studies, and risk management. Prepare, compile, and follow up on pre-market and post-market submissions. Monitor and interpret new and updated regulations, ensuring internal stakeholders are informed. Update and manage regulatory procedures to support continuous process improvements. Support stakeholders in implementing new regulatory requirements and on-market activities.

What We Expect

Education: Bachelor’s degree in life sciences, engineering or a similar discipline 

Knowledge: Understanding the regulatory standards for IVD’s and medical devices is advantageous 

Skills: Strong communication skills, and the ability to interpret and explain standards to cross functional stakeholders 

Curiosity: An interest in the life science field, and a passion to continue learning the changes in requirements landscape 

Organisation: Strong organisational skills with the ability to pivot across numerous projects at any time. Ability to work in a fast-paced environment

Independence and Initiative: Proactive approach to your work, with the mindset of continuous improvement and development of processes and ideas

 

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

Our talent partners can discuss our salary offering and any relevant bonus schemes with you.

We look forward to hearing from you!

Location: Liege

Hybrid: On-site 2-3 days per week 

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