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