Principal, Regulatory Affairs Specialist

Il y a 2 mois

Leuven, Belgique Danaher Temps plein

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position is part of the Quality Assurance and Regulatory Affairs department located in Leuven, BE and is hybrid. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things

In this role, you will have the opportunity to:

  • Prepare technical documentation in compliance with IVDR to support CE marking of in vitro diagnostic products and submission for review to notified body; provides advanced knowledge to support internal and external audits.   
  • Lead assessment, guidance and completion of required competent authority submissions and interactions in EU member states; collaborates with international colleagues in global regions to submit application/registration documents.
  • Review and approve regulatory/quality documentation related to new product development deliverables acting as core team member conducting regulatory assessments related to design changes, advising and approving protocols, reports, marketing material, etc. 
  • Interprets new and/or existing regulatory requirements ensuring compliance with applicable agency requirements, published standards, local procedures and project specific plans.
  • Coordinates and acts as primary POC for communication with notified bodies, competent authorities and medical device reporting activities, including post-market surveillance, adverse events, and field actions.
  • Other accountabilities as assigned

The essential requirements of the job include:

  • Bachelorâs degree in a technical field such as chemistry, biochemistry, biology, or related field required.
  • Minimum 5 years of experience in regulated environment required; 5+ years of global regulatory experience related to in vitro diagnostics required.
  • Knowledge and experience in EU IVD regulations and post-market surveillance activities.  
  • Experience and understanding of product development process inclusive of Design Control and Risk Management; broad knowledge and previous application of ISO 13485.  

It would be a plus if you also possess previous experience in:

  • Advanced degree in technical field such as chemistry or biochemistry preferred
  • Strong collaborative facilitation skills with the ability to build consensus while championing global regulatory compliance.
  • Ability to work independently utilizing developed research and analytical skills to manage multiple projects.

At IDT we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for IDT can provide.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Companyâs sole discretion, consistent with the law.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs 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. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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