ProClinical Life Sciences Recruitment Blog

Owen Bach

Recent Posts

What will happen if you don’t comply with the MDR and IVDR?

Posted by Owen Bach

07/12/17 12:30

Simply put, failing to comply with the new medical device (MDR) and in-vitro diagnostic (IVDR) regulations is not an option for companies that wish to continue developing these devices once the transitional period comes to an end in 2021. The regulations are absolutely critical to the future success of medical devices companies. Here’s why:

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

How will the changing role of Notified Bodies after the MDR and IVDR affect your company?

Posted by Owen Bach

30/11/17 12:30

Perhaps one of the most significant changes from the recent EU medical device regulations is the reformed role of Notified Bodies. Previously seen as ‘industry partners’ that would assist medical device companies with compliance and conformity assessments, Notified Bodies will now be the primary enforcers of the new regulations. This is an effort to ensure that they are fully qualified to oversee certified products, and that more emphasis is put on high-risk devices.

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

What is the new classification system for medical devices and IVDs following the MDR and IVDR?

Posted by Owen Bach

29/11/17 12:00

In May 2017, the European Parliament published a set of regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) that will require companies to make significant changes to their manufacturing, clinical investigation, quality assurance and data reporting processes. To read more about these transformative pieces of legislation, download our comprehensive guide. This article will explore the impact of the new classification system, for manufacturers of both medical devices and IVDs.

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

What you need to know about the changes to EU medical devices (MDR) and in-vitro diagnostics (IVDR) regulations (2017)

Posted by Owen Bach

28/11/17 15:30

The new EU medical device and in-vitro diagnostic regulations are an effort by the European Parliament and Council to improve the manufacture and marketing processes of medical devices to ultimately ensure greater patient safety.

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

How to get a validation engineer job

Posted by Owen Bach

12/01/17 15:20

Validation engineers are an integral part of the operation and manufacturing process of any pharmaceutical, biotechnology and medical device company. They carry out crucial functions to ensure that drugs and treatments are safely and effectively produced for patients all over the world. Validation engineer jobs are on the rise and always in demand, so take some time to explore if becoming a validation engineer could be the right career for you, and how to find a way in. 

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Topics: Career advice

How to get a chemical engineer job in the pharmaceutical industry

Posted by Owen Bach

04/05/16 13:00

Interested in the pharmaceutical industry? We don’t blame you. According to the World Health Organization, “the global pharmaceuticals market is worth US$300 billion a year, a figure expected to rise to US$400 billion within 3 years.” In other words, the pharmaceutical industry is booming, and the growth opportunities are truly endless. As a chemical engineer, you are an integral part to any pharmaceutical organisation. However, since the industry is so hot right now, getting your foot in the door can prove rather difficult.


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Topics: Career advice, Applying for jobs

About this blog

ProClinical is one of the leading recruitment agencies in the life sciences sector. Blogs are written by ProClinical recruitment consultants and experts within the recruitment and life sciences industries. This blog features advice on finding new jobs and career planning, as well as life sciences news and hiring tips for employers.

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