Regulatory Affairs Specialist Salary in Waterloo, Ontario

Regulatory Affairs Specialist job description

Job Title: Regulatory Affairs Specialist

Overview/Summary of the Role:

The Regulatory Affairs Specialist is responsible for ensuring that all products, processes and equipment used by an organization comply with all relevant regulatory requirements. They work with internal teams and external regulatory bodies to ensure that all necessary licenses, approvals, and registrations are obtained in a timely and efficient manner.

Responsibilities and Duties:

-Develop and implement regulatory strategies for new and existing products

-Ensure compliance with all applicable regulations and standards, including FDA, EMA, and other regulatory bodies

-Prepare and submit regulatory filings, including product registrations, 510(k) submissions, and other required documentation

-Stay up-to-date with new regulatory developments and communicate updates to relevant stakeholders

Regulatory Affairs Specialist interview questions

Interviewer: Hello, thank you for coming in to interview for the Regulatory Affairs Specialist position. Can you please start by introducing yourself and sharing your background in regulatory affairs?

Candidate: Thank you for having me. My name is Jane Doe and I have a Bachelor's degree in biology. I have worked in regulatory affairs for the past five years, primarily in the medical device industry.

Interviewer: Great, can you describe your experience with FDA regulations and approvals?

Candidate: Yes, I have experience with preparing and submitting 510(k) applications and IDEs for FDA approval. I am familiar with FDA regulations and have worked closely with their personnel during the approval process.

Interviewer: How do you ensure compliance with regulatory requirements during product development?

Candidate: I work closely with the product development team to identify potential regulatory issues early on in the process. I also use established procedures and checklists to ensure that all necessary regulatory requirements are met.