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.

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. Apply to regulatory affairs manager quality assurance manager senior safety manager and more. Apply to regulatory specialist and more. Apply to regulatory affair specialist senior regulatory affair specialist senior regulatory affair engineer and more.

The duties and responsibilities of regulatory affairs specialists have expanded in recent years as a result. Familiarity with medical device or diagnostics industry standards and regulatory requirements e g. Regulatory affairs is a comparatively new business administration function. They may also work in government or law.

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 associates occupy one career niche within the larger regulatory affairs profession which exists in many industries. 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 specialists assist in obtaining and maintaining government approval for drugs medical devices nutritional products and related materials.

30 days ago save job not interested report job. They are often employed by pharmaceutical biotechnology and medical device companies. Medical device companies also rely on their regulatory affairs team after a device is cleared or approved.