Associate Regulatory Affairs Specialist - 18 months contract (Brampton)

Associate Regulatory Affairs Specialist - 18 months contract (Brampton)

03 Oct
|
Medtronic
|
Brampton

03 Oct

Medtronic

Brampton

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.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.Define the regulatory strategy and manage regulatory submission activities for product maintenance for existing approved products.Team with other Regulatory Affairs Specialists (RAS) and international regulatory team to provide regulatory support changes to existing products.

Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.Prepare regulatory submissions for product changes, as required, to ensure timely approvals for market release.This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.Interact directly with regulatory agencies on most projects/products at reviewer level. Support regulatory compliance activities,



including manufacturing site registration, audits, etc., Maintain proficiency in worldwide regulatory requirements; Provide local regulatory assessments to international regulatory team to enable development of strategies and requirements and communicate that information to business teams.Ensure personal understanding of all quality policy/system items that are personally applicable.Follow all work/quality procedures to ensure quality system compliance and high-quality work.Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.DIFFERENTIATING FACTORSAutonomy: Entry-level individual contributor on a project or work team.Works with close supervision.Delivers work of limited scope, typically smaller, less complex projects or related activities.Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.Communicates primarily with internal contacts within immediate group.Nice to have• Experience in regulatory affairs through internship role/s, preferably in the medical device industrySalary Range:



$64000 - $80000PLEASE NOTE:We use artificial intelligence (AI) to review resumes of candidates and assess their fit based on the criteria outlined in the job posting.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

For Office Roles: The employee is also required to interact with a computer and communicate with peers and co-workers.Medtronic Canada strives through our vision to build a culture of inclusiveness through our commitment to employment equity and diversity. Discrimination is prohibited on any grounds protected under Canadian Human Rights legislation. Employment applications are encouraged from all members of our community.

Upon request, candidates with disabilities will be accommodated during the recruitment process.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected] & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values.

They share in the success they help to create.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

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📌 Associate Regulatory Affairs Specialist - 18 months contract (Brampton)
🏢 Medtronic
📍 Brampton

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