Associate Regulatory Affairs Specialist - 18 months contract

Socket.dev; Brampton; On-site; CAD 64,000 - 80,000; Full time

Job summary

Medtronic Canada is seeking a regulatory affairs specialist to direct regulatory submissions and coordinate documentation for submissions, audits, and inspections.

You will work with international teams to provide regulatory support for changes to existing products, review labeling and promotional material, and interact with regulatory agencies on defined matters. A Bachelor’s degree is required, with internship in regulatory affairs preferred.

Qualifications

• Requires broad theoretical knowledge typically obtained through advanced education.
• Experience or internship in regulatory affairs preferred in medical devices.

Responsibilities

• Directs or coordinates regulatory submissions and preparation of document packages for submissions, audits and inspections.
• Leads materials required for submissions, license renewals and registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking and control systems.
• Keeps abreast of regulatory procedures and changes.
• Interact with regulatory agencies on defined matters.

Skills

Regulatory strategy

Regulatory submission support

Interfacing with agencies

Education

Bachelor's degree

Job description

Careers that change lives start here. 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.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• 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 Health Canada applications.

Additional Responsibilities:

• 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.
• Review significant product submissions with manager and negotiate submission issues with agency personnel.
• Provide support to currently marketed products as necessary. 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. All significant issues will be reviewed with the manager.
• Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• 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.

SPECIALIST CAREER STREAM:Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. 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 FACTORS

Autonomy:Entry-level individual contributor on a project or work team.
Works with close supervision.

Organizational Impact:Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity:Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems .

Communication and Influence:Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.

Leadership and Talent Management:N / A – job at this level is focused on self-development .

Required Knowledge and Experience:Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree.

Nice to have

• Experience in regulatory affairs through internship role/s, preferably in the medical device industry

Salary Range: $64000 - $80000

PLEASE NOTE:

• We use artificial intelligence (AI) to review resumes of candidates and assess their fit based on the criteria outlined in the job posting. We do not use AI to make any final hiring or interview decisions.

• This posting reflects a current, genuine vacancy that we are actively recruiting to fill

PHYSICAL JOB REQUIREMENTS

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, 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.

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.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. 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.