Regulatory affairs – taking care of business

  • By lucy
  • 14 September, 2017

A large part of the customer service at Boddingtons includes services in legal and regulatory affairs. This aspect is particularly important in relation to new product launches, and in most work done for sectors such as healthcare and medical.

We talked to Shimaa Elsawy about her essential work in this area at Boddingtons.

Shimaa – welcome to the website blog. Firstly, what prior work experience has led you to your current role at Boddingtons?

My previous experience in regulatory affairs and Quality Assurance (QA) in the medical devices industries qualified me to join Boddingtons. I have been working in the field of medical devices regulatory affairs for over ten years, in which time I gained broad experience in launching new products into EMEA markets.

What variety of work does your job involve at Boddingtons?

Our aim at Boddingtons is to work with individuals and businesses; to understand their needs and, with our knowledge of the regulatory requirements, to then help build system and processes that are effective and fit for their purposes.

In more detail, we provide:

A solution-driven approach to compliance with the current medical devices’ regulations in EU and USA.

Technical files construction for CE marking approval.

The creation, updating, submission and maintainance of medical devices technical files.

Research and regulatory vigilance over regulatory changes.

Liaison with regulatory and competent authorities in order to ensure that compliance in medical devices is maintained.

Regular research into medical devices regulatory requirements in order to aid the Boddingtons business in meeting customer needs.

What do you enjoy most about your expertise at Boddingtons?

It gives a great sense of satisfaction to work closely with our business partners – particularly at the early stages of new medical device development. We need to advise the client on the main regulatory elements to consider at the time that the device is to be launched.  Taking care of compliance matters at the outset helps launch the customer’s product into the market within an optimum and shortened time frame.

Why/how do regulatory affairs matter at Boddingtons?

The regulatory function is critical at Boddingtons because it assures our customers that Boddingtons’ products absolutely fulfil the essential regulatory requirements for each market where they will be registered and sold. Compliance with the essential regulatory requirements of each marketplace is mandatory in order to continue selling the products after registration.

And what do you enjoy most about company life at Boddingtons?

I enjoy giving direct support to senior management in a way that really makes a difference: The contribution I make is vital to the company’s ability to make key operational decisions; ultimately influencing the overall direction and success of the business.  I enjoy the challenge and the responsibility. I also enjoy the methodical and precise disciplines that are needed in order for me to deliver the information that the management relies upon.

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