The duties and responsibilities of regulatory affairs specialists have expanded in recent years as a result.
Medical device regulatory affairs job description.
Familiarity with medical device or diagnostics industry standards and regulatory requirements e g.
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Regulatory affairs associates occupy one career niche within the larger regulatory affairs profession which exists in many industries.
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These departments can be found in a variety of companies that manufacture pharmaceuticals drugs medical devices cosmetics and industrial chemicals.
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Regulatory affairs is a comparatively new business administration function.
They may also work in government or law.
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Regulatory affairs associates are often employed by pharmaceutical or medical devices companies and assist in obtaining government approval for drugs medical devices veterinary products cosmetics and foods.
Regulatory affairs officers act as a link between companies and regulatory authorities ensuring that products are manufactured and distributed in compliance with appropriate legislation.
In the postmarket setting the regulatory function is involved in device surveillance ensuring that any adverse events or malfunctions are appropriately reported to fda.
Medical device companies also rely on their regulatory affairs team after a device is cleared or approved.