Medical Device Regulatory Affairs Job Description

Regulatory affairs officers act as a link between companies and regulatory authorities ensuring that products are manufactured and distributed in compliance with appropriate legislation. 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. Medical device companies also rely on their regulatory affairs team after a device is cleared or approved.

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Medical device regulatory affairs job description.

Qsr iso13485 2017 745 2017 746. The organisation for professionals in regulatory affairs explains on its website that a. In the postmarket setting the regulatory function is involved in device surveillance ensuring that any adverse events or malfunctions are appropriately reported to fda. Apply to regulatory affairs manager quality assurance manager senior safety manager and more.

Familiarity with medical device or diagnostics industry standards and regulatory requirements e g. Regulatory affairs is a comparatively new business administration function. The duties and responsibilities of regulatory affairs specialists have expanded in recent years as a result. These departments can be found in a variety of companies that manufacture pharmaceuticals drugs medical devices cosmetics and industrial chemicals.

Regulatory affairs specialists assist in obtaining and maintaining government approval for drugs medical devices nutritional products and related materials. Apply to regulatory specialist and more. They are often employed by pharmaceutical biotechnology and medical device companies. They may also work in government or law.

Regulatory affairs associates occupy one career niche within the larger regulatory affairs profession which exists in many industries. Apply to regulatory affair specialist senior regulatory affair specialist senior regulatory affair engineer and more. Apply to regulatory specialist medical device regulatory affairs development rad program senior engineer and more.

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