Regulatory Affairs Specialist

Medtronic•Brampton, ON

13d•$73,520 - $91,900•Onsite

About The Position

This position is responsible for leading and coordinating the preparation of regulatory submission packages across all company functions, including internal audits and inspections. It ensures the compilation of all required documentation for submissions, license renewals, and annual registrations in compliance with local regulations. The role also provides regulatory guidance by recommending updates to labeling, manufacturing, marketing, and clinical protocols, while maintaining oversight of tracking and control systems to ensure continuous improvement. Additionally, it supports interactions with regulatory authorities and contributes to strategies that facilitate timely approvals, including clinical trial applications.

Requirements

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Nice To Haves

The employee is regularly required to be independently mobile.
The employee is also required to interact with a computer and communicate with peers and co-workers.

Responsibilities

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.