Regulatory Affairs – A booming sector of opportunities

Roles of Regulatory Affairs Specialist in Medical Device Manufacturing

Regulatory Affairs is one of the major departments in a company which plays a crucial role in getting the developed product released into the market. This varies from country to country and market to market. For example, the standards and regulations are different for different country like the FDA for USA, CE Marking for the European Union etc. So, when a particular product is getting developed itself it has to be done in accordance to these Standards and Regulations so that it can surpass these testing standards and get released into the market. On the other hand, when a product developed in one country according to their standards, needs to be exported or sold in a different country then the same product need to be tested and certified according to the target market/country’s standards. Thus the entire process of Regulations are simplified and made feasible typically by the Regulatory professionals.

In the earlier decades the Regulatory Affairs Specialists were involved only in the final stage after the complete development of device but in the current times the Regulatory professionals play an extremely crucial role throughout the lifecycle of the product from the conceptualization to the post-market surveillance.

Few of the most critical tasks performed by the Regulatory professionals during various stages are

  • Concept and Feasibility Stage: During this stage the Regulatory professionals guide the R&D team to balance the concepts between the usage of novel and existing ideas depending on the target. This is because in the cases where there is a complete novelty the device has to go through PMA which is very expensive and time consuming, hence the Regulatory professionals collect all the details about the existing predicate and its relevance to the product being developed.
  • Preclinical Stage: A Regulatory professional would help the R&D determine the most efficient, effective, and compliant testing strategy. Because a product possessing a predicate with existing test strategies would save money and time.
  • Manufacturing and Production Stage: The Manufacturing team needs to consult the Regulatory professionals before implementing any change in the design and control as even the smallest change made must be complaint to all the stipulated regulations.
  • Marketing stage: A Marketing team usually plans and comes up with potential claims while the device is still in the early concept and prototyping stage. The Regulatory professionals verify these claims and points in such a way that they don’t raise any red flags in future.
  • Post Market Stage: The Regulatory professionals need to keep track of the following in order to sustain the quality and also to keep the details in track for future devices.
    • Who is using the device
    • How the device is performing months and even years after a procedure
    • How similar devices are performing
  • In short, the Regulatory professionals ensure that
    • A predicate exists that the FDA will accept
    • There’s a solid risk management plan in place
    • FDA guidance documents for testing are adhered to
    • All available standards and literature for testing are evaluated and applied where appropriate.
  • It is important to get the Regulatory strategies aligned to the company’s goals.


Thus, the Regulatory professionals secure the reputation of the Manufacturer by sustaining the provision of completely quality complaint products.

Given the increase in concerns and complexities about the products, new standards and regulations keep emerging at a very fast and frequent pace. Hence there exists a lot of scope for Regulatory professionals amongst the Medical Device and Pharmaceutical Industries.


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