How much does a regulatory affairs specialist make in Canada?

How much does a regulatory affairs specialist make in Canada?

The average salary for a regulatory specialist is $65,712 per year in Canada.

Who regulates medical devices in Canada?

Who regulates medical devices in Canada? The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.

How do I get into medical device regulatory affairs?

A detailed account of these basic steps follows.

  1. Step 1: Earn a bachelor’s degree (four years).
  2. Step 2: Get practical experience in the field (one to four years).
  3. Step 3: Complete advanced coursework in regulatory affairs (one to five years).
  4. Step 4: Obtain certification (several weeks or months).

How medical devices are regulated in Canada?

In Canada, you are required to obtain a Medical Device Establishment License (MDEL) if you intend to market your Class I device, or a Medical Device License (MDL) for your Class II, III or IV device. If you intend to distribute licensed medical devices into Canada, you will require a MDEL.

What does a regulatory affairs Associate do?

A regulatory affairs associate is in charge of learning and implementing company policies and government regulations, ensuring compliance in every aspect of the company.

What is regulatory work?

What is regulatory affairs? Regulatory affairs is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use.

What is the equivalent to the FDA in Canada?

Health Canada
The U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other’s food safety systems as comparable to each other.

What is a Class 4 medical device in Canada?

Class IV: High-risk devices such as pacemakers and surgically invasive devices that diagnose, control, or correct a defect in the central cardiovascular system. The device manufacturer, importer, or distributor is responsible for classifying the device.

Is it hard to get into regulatory affairs?

Skilled regulatory affairs candidates are in high demand and vacancies for senior regulatory positions are easy to find, but many roles require experience and that can be hard to get.

Is regulatory affairs a good job?

A career in Regulatory affairs is one of the versatile professions one can ever come across because it provides diversified employment opportunities that too at various levels. Even though Regulatory Affairs is one of the most interesting and rewarding careers but still it has its own challenges.

What is a Class 3 medical device in Canada?

Class III: Medium-to-high risk devices such as hip implants, glucose monitors, ultrasound diagnostic imaging equipment, and surgically invasive devices that are intended to be absorbed into the body or that are intended to remain in the body for at least 30 consecutive days.

What is a Class 1 medical device Canada?

1. Class I: Low risk devices such as wound care and non-surgically invasive devices. 2. Class II: Low-to-medium risk devices including contact lenses and the majority of surgically invasive devices (e.g., surgical gloves, needles, magnetic resonance imaging equipment).