ProClinical Life Sciences Recruitment Blog

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:

In an already competitive market for talent, the task of assembling a highly skilled workforce to carry out your compliance plan for the new medical device regulations will be no easy feat. Getting the right people in place will undoubtedly affect your existing workforce, but the most important aspect to consider will be the additional personnel you’ll need to set your company’s compliance plan in motion. Here are some steps to follow to get the right people in place for the MDR & IVDR:

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.

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.

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.

Chemistry, Manufacturing and Controls (CMC) is a specific and significant aspect of regulatory affairs, which is found within many different types of company, particularly pharmaceutical companies that develop and manufacture drugs. ProClinical is giving some inside tips on how to progress your regulatory affairs CMC career within pharma.

In the highly competitive job market for regulatory affairs professionals, having a well crafted CV is critical to secure a position at a pharmaceutical company, contract research organisation, consultancy or other life sciences company. Your CV represents your elevator pitch. When human resources or a hiring manager reviews your application, you have one minute of their time to explain who you are and why you would be a terrific fit for their open regulatory affairs associate role. 

Every pharmaceutical company's goal is to get its drugs to market, and if you work in pharmaceutical regulatory affairs, achieving marketing authorisation for your medicinal product is often the most satisfying aspect of your job. Here’s what you need to know about the marketing authorisation application process (and the technical jargon) for regulatory affairs in the pharmaceutical industry.

Interview preparation is key to being able to properly represent yourself to a potential employer. In regulatory affairs there are some key aspects that employers consistently look for in a job interview. With a bit of groundwork, you will be able to show these skills and increase your chances of getting the job.

Regulatory affairs is a vital function in safeguarding the health and wellbeing of millions of people worldwide but regulatory affairs jobs can be a difficult to attain for graduates and even those looking to move from other specialities with relatable skills. Here's our advice about how to get your foot on the ladder and start your career in regulatory affairs.