Regulatory Affairs Specialist

Medtronic; Brampton; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading healthcare technology company located in Peel Region, Brampton is seeking a Regulatory Affairs Specialist. In this role, you will evaluate and recommend submission pathways for medical devices, prepare regulatory applications, and ensure compliance with Health Canada. The ideal candidate will possess a Bachelor's degree with a minimum of 2 years of relevant experience, strong problem-solving abilities, and excellent communication skills. This position offers a competitive salary along with a flexible benefits package designed to support employee needs.

Benefits

Competitive salary

Flexible benefits package

Short-term incentive plan (MIP)

Qualifications

• Requires a minimum of a Bachelor's degree and 2 years of relevant experience.
• Experience in preparation and filing of regulated medical product applications is essential.
• Bilingual in French and English is preferred.

Responsibilities

• Evaluate and develop strategic submission pathways for medical device applications.
• Lead coordination of document packages for regulatory submissions.
• Ensure compliance with Health Canada and maintain regulatory records.

Skills

Problem-solving

Organizational skills

Detail-oriented

Interpersonal skills

Verbal communication

Written communication

Education

Bachelor's degree in related field

Advanced degree in Life Sciences

Job description

At Medtronic you can begin a life‑long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Reporting to the Manager Regulatory Affairs, the Specialist, Regulatory Affairs will evaluate, develop and recommend strategic submission pathways, options and strategies for departmental assignments. He/She will prepare the various medical device applications and combined product submissions to meet regulatory agency requirements and ensure follow‑up until approval. Moreover, he/she will support quality‑related tasks.

Responsibilities

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

• Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits and inspections.
• Lead or compile all materials required in submissions, license renewal and annual registrations.
• Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitor and improve tracking/control systems.
• Keep abreast of regulatory procedures and changes.
• Direct interaction with regulatory agencies on defined matters.
• Recommend strategies for earliest possible approvals of clinical trial applications.
• Report complaints and adverse drug reactions (ADR).
• Maintain ongoing dialogue with business partners to develop strategies aligned with the business plan.
• Obtain proper product and technical documents for the purpose of preparing license applications for filing in Canada.
• Ensure timely completion of regulatory submissions and applications and related amendments.
• Maintain professional relationship with Health Canada.
• Ensure all regulatory records/documents are properly and adequately maintained in accordance with regulatory requirements and internal processes.
• Support or lead special regulatory business projects and assignments as required.
• Collaborate with Marketing and Global Regulatory Teams on a regular basis to assess and prioritize submissions to Health Canada.
• Participate in product launch activities as required.
• Provide Health Canada with all necessary technical information relating to changes or modifications to regulated medical products (i.e. drugs, devices, CTO etc.).

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 direct the work of other lower‑level professionals. The majority of time is spent delivering and overseeing projects – from design to implementation – while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Differentiating Factors

Autonomy

Establishes and maintains a productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.

Organizational Impact

• Sets objectives for own job area to meet the objectives of projects and assignments.
• Contributes to the completion of project milestones.
• May have some involvement in cross‑functional assignments.

Innovation and Complexity

• Problems and issues faced are general, may require understanding of broader set of issues or other job areas but typically are not complex.
• Make adjustments or recommend enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence

• Primarily and frequently communicates with internal contacts.
• External interactions are less complex or problem‑solving in nature.
• Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision‑making.

Leadership and Talent Management

May provide guidance and assistance to entry‑level professionals and/or employee in Support Career Stream.

Required Knowledge and Experience

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.

Required Qualifications

Knowledge/Education

• Bachelor's degree, or
• Advanced degree in Life Sciences

Job Experience

• Minimum of 2 years of relevant experience, with a bachelor's degree, or
• No minimum years relevant experience, with an advanced degree.
• Experience in the preparation and filing of regulated medical product applications.

Competencies

• Strong problem‑solving and organizational skills and able to work with minimum supervision.
• Detail oriented, accurate and results driven.
• Ability to think strategically and work in cross‑functional teams.
• Ability to manage multiple priorities in a fast‑paced environment.
• Team player with very strong interpersonal skills.
• Excellent verbal and written communication skills.

Skills/Competencies

• Working knowledge of the Food and Drugs Act and associated Regulations.
• Knowledge of Quality System Requirements.

Additional Requirements

• Must be computer literate using Microsoft software (i.e., Word, Excel, PDF, etc.).

Desired/Preferred Qualifications

Knowledge/Education

• Postgraduate certificate in Regulatory Affairs.
• Knowledge of Cybersecurity and/or Artificial Intelligence as an asset.
• Knowledge of CTO Regulations.

Job Experience

• 3–5 years of relevant experience.

Skills/Competencies

• Bilingual French/English.

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.

This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.