Regulatory challenges are omnipresent in the medical device industry.
The role of regulatory affairs for a medical device manufacturer is to ensure product compliance with current regulations before, during, and after market launch.
Today, the tightening of regulatory requirements is a major concern for companies, especially with the introduction of the new Medical Device Regulation MDR 2017/745, new requirements related to ISO 13485, Regulation 2017/745, Regulation 2017/746 for IVD devices, ISO 62304, both at the national and international levels (FDA).
These are quite technical terms but remain a central topic for companies.
Moreover, with the development of artificial intelligence (AI) solutions, the rules are set to evolve. Regulatory affairs is a very dynamic field, which is why companies are currently looking for profiles in QARA.
This year, we have recruited various profiles: regulatory affairs officer, specialist, QARA director, quality manager, senior project manager for all types of companies—SMEs, startups, and large groups in France and internationally.
These roles intervene upstream of commercial strategy, working closely with sales, marketing, and R&D teams. For example, the regulatory affairs officer implements the company’s regulatory strategy before product commercialization to ensure compliance with regulations. They also monitor the dossiers requested by health authorities. In a startup, this role is central.
A few months ago, we had the opportunity to recruit the first person responsible for regulatory affairs in a medical device startup. She confirmed that she holds a decisive position within the company, interacting with all departments. She trains her colleagues and raises awareness of regulatory issues. She is a young graduate thriving in her new role!
Regulatory affairs are part of the company’s strategy. Under the new regulation, manufacturers must have at least one person within their organization responsible for ensuring regulatory compliance, possessing the required expertise in medical devices (or in vitro diagnostics for IVDR).
However, these medical device manufacturers face a shortage of resources.
If you have a scientific and biomedical background and are looking for a career with growth potential, where you will interact with various company departments, we would be happy to guide you through this environment. Contact us!
If you are not yet familiar with all these terms and want to learn more about regulatory affairs, join us for a webinar on this topic in November.
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Céline Efaiki
Community Manager
