Regulatory Affairs Specialist IVD
job description

Title: Regulatory Affairs Specialist – In Vitro Diagnostics (IVD)

We have an exciting opportunity for a skilled Regulatory Affairs Specialist, specialized in the In Vitro Diagnostics (IVD) sector, to join our dynamic team.

We are a market-leading, globally influential organization specializing in diagnostic solutions, committed to enhancing patient outcomes through innovative technologies. If you possess a profound understanding of the IVD regulations, with a passion for bridging the gap between diagnostic technology and patient safety, we would love to hear from you!

As an IVD Regulatory Affairs Specialist, you will play a pivotal role in the product life cycle management of our diagnostic products. Your key responsibilities will include advising on and coordinating appropriate global regulatory strategies to ensure swift and successful product registrations. Further, you will take the lead on regulatory submissions, interfacing actively with regulatory bodies.

Ideal candidates for this role will be confident professionals possessing a relevant degree in life sciences or medical technology, complemented by at least two years of experience in a similar role within the IVD industry. Exceptional knowledge of local and international regulatory standards, excellent communication skills, and the ability to tackle complex problems are also a must.

Key Qualifications:

- Bachelor's degree in Life Sciences, Medical Technology or a related field
- Minimum two years’ experience in Regulatory Affairs within the IVD industry
- Comprehensive understanding of local and international regulatory requirements
- Excellent communication, problem-solving and organizational skills

In return, we offer a competitive salary package, opportunities for professional development, a supportive work environment, and the chance to make a real impact on patient lives.

Join us to excel in a career that not only challenges and motivates but also makes a significant contribution towards accelerating effective patient healthcare solutions.

Wait no more, if you meet the above criteria and are excited about this opportunity. Apply now to become a part of our dynamic organization.

Keywords: Regulatory Affairs, Regulatory Affairs Specialist, In Vitro Diagnostics, IVD, Life Sciences, Medical Technology, International Regulatory Standards, Product Life Cycle Management, Patient Healthcare Solutions.