What is the role of regulatory affairs in medical devices?

The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.

Do you have what it takes for a career in regulatory affairs?

The field of regulatory affairs offers career stability and plenty of room for advancement. You’ll get to make a tangible difference by ensuring that the pharmaceuticals, medical devices, cosmetics, foods, and nutritional products that we all use are safe and effective.

How do I become a medical regulatory affairs?

The minimum requirement for aspiring regulatory affairs specialists is a bachelor’s degree. Regulatory affairs workers come from a wide variety of fields. Many of them possess undergraduate degrees in engineering, clinical sciences, or public health.

What is a medical device regulatory affairs career path?

Regulatory affairs professionals serve a critical function throughout a medical device’s product lifecycle—leading premarket strategy, drafting regulatory submissions, and ensuring postmarket compliance. Here’s a closer look at each of those phases. Learn how to navigate the discipline and accelerate your regulatory career.

What is it like to work in Regulatory Affairs as an RA?

Keeping close track to regulatory changes and interpreting its implications on the drug development and authorization process is part and parcel of life in regulatory affairs. RA professionals need to be able to synthesizes complex information and convert it in a comprehensible manner especially during project team meeting.

What is the scope of pharmaceutical regulatory affairs in India?

As a professional in the regulatory affairs area, one can work in drug development industries, food industry, cosmetic industry etc. In India, admission into pharmaceutical regulatory affairs is provided as a post-graduate program in Pharmacy .

What does a medical device regulator do?

Regulatory affairs professionals serve a critical function throughout a medical device’s product lifecycle—leading premarket strategy, drafting regulatory submissions, and ensuring postmarket compliance. Here’s a closer look at each of those phases. Download Our Free Guide to Advancing Your Regulatory Affairs Career

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