Changes in medical device directive likely to affect future recruitment trends

Stephen O'Brien 18.07.2011

Following my previous commentary on recruitment trends within the pharmaceutical and medical device sectors (read here), the last quarter has shown a consistent level of demand for talent throughout the medical device industry in particular. Quality Assurance remains high on the agenda of most companies, and recent developments pertaining to the regulations surrounding medical devices indicate that in the medium-to-long term, candidates with strong QA backgrounds in both medical device and pharmaceutical will be in high demand.
Following a number of high-level meetings among international regulatory groups earlier this year, it is likely that the EU medical device directive will soon be recast to cover the increasingly high number of combination medical device products.
Combination products are defined as any product combining a medical device with a medicinal product, i.e. antibiotic-coated catheters or drug-eluting stents. Concerns had previously been raised by a number of groups as to the relative lack of regulation of such products, considering the stringency of regulation for pharmaceuticals where they are sold as stand alone products.
When it is considered that a qualified person must review the disposition of medicinal products on a batch-to-batch basis, it is surprising a device which carries and delivers an API is not yet subject to same levels of regulation and post-release vigilance.
The impending restructuring of the medical device directive to address these concerns is likely to bring with it increased demand for QA, Vigilance and Regulatory Affairs staff. I have recently seen an increase in the numbers of quality and risk management positions within the medical device sector, with a number of mid to senior-level candidates communicating to me a desire to gain experience in this sector to develop their skills for future career moves. As per my previous blog entry, candidates with broad QA and Regulatory Affairs backgrounds continue to be the most sought-after among my clients; as such I invite those with these backgrounds to contact me for an informal discussion on market opportunities. 

Following my previous commentary on recruitment trends within the pharmaceutical and medical device sectors, the last quarter has shown a consistent level of demand for talent throughout the medical device industry in particular. Quality assurance remains high on the agenda of most companies, and recent developments pertaining to the regulations surrounding medical devices indicate that in the medium-to-long term, candidates with strong QA backgrounds in both medical device and pharmaceutical will be in high demand.

Following a number of high-level meetings among international regulatory groups earlier this year, it is likely that the EU medical device directive will soon be recast to cover the increasingly high number of combination medical device products.

Combination products are defined as any product combining a medical device with a medicinal product, i.e. antibiotic-coated catheters or drug-eluting stents. Concerns had previously been raised by a number of groups as to the relative lack of regulation of such products, considering the stringency of regulation for pharmaceuticals where they are sold as stand alone products.

When it is considered that a qualified person must review the disposition of medicinal products on a batch-to-batch basis, it is surprising a device which carries and delivers an API is not yet subject to same levels of regulation and post-release vigilance.

The impending restructuring of the medical device directive to address these concerns is likely to bring with it increased demand for QA, vigilance and regulatory affairs staff. I have recently seen an increase in the numbers of quality and risk management positions within the medical device sector, with a number of mid to senior-level candidates communicating to me a desire to gain experience in this sector to develop their skills for future career moves.

As per my previous blog entry, candidates with broad QA and regulatory affairs backgrounds continue to be the most sought-after among my clients; as such I invite those with these backgrounds to contact me for an informal discussion on employment opportunities. 

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Director
sobrien@morganmckinley.ie