What does a director of regulatory affairs do?

A regulatory affairs director works in the private sector, guiding the direction a company takes as it prepares and unveils new products to the market. She oversees compliance and timing as well as defining and paving the ways for government approvals.

How much do regulatory affairs directors make?

The average salary for a director of regulatory affairs is $119,752 per year in California.

What does medical device regulatory affairs do?

Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. They are often employed by pharmaceutical, biotechnology, and medical device companies. They may also work in government or law.

How much do regulatory affairs professionals make?

The average Regulatory Affairs Specialist salary in the United States is $183,623 as of August 27, 2021. The range for our most popular Regulatory Affairs Specialist positions (listed below) typically falls between $54,472 and $312,773.

What is the role of Regulatory Affairs in the medical device industry?

Regulatory affairs professionals serve a critical function throughout a medical device’s product lifecycle—leading premarket strategy, drafting regulatory submissions, and ensuring postmarket compliance.

Are there regulations for medical devices around the world?

Many countries throughout the world have their own medical device regulations, however, and regulatory affairs is required to understand the differences in global regulatory requirements to ensure that new products can be marketed.

What do you need to know about regulatory affairs?

The submission must then demonstrate that the new device is substantially equivalent to the predicate one. If no predicate is available, regulatory affairs must submit a premarket approval application, or PMA, to demonstrate that the device is safe and effective for its intended uses.

What is the role of the medical device industry?

The medical device industry plays a key role in the healthcare ecosystem by providing innovative solutions that improve patient outcomes. Every company seeks to innovate, whether through iterative updates to existing technology or by developing new devices that could offer a more effective treatment to a particular disease or condition.

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