Associate Regulatory Affairs Specialist - 18 months contract

CAN Medtronic Canada ULC; Brampton; On-site; CAD 64,000 - 80,000; Full time

Job summary

Medtronic Canada ULC is seeking a regulatory affairs specialist to coordinate regulatory submissions, oversee license renewals, and ensure compliance across product changes. You will work with cross-functional teams to prepare documentation and interact with Health Canada to achieve timely approvals.

The role requires a Baccalaureate degree and offers opportunities to contribute to product maintenance, labeling reviews, and global regulatory strategies within a leading medical device company.

Qualifications

• Broad theoretical knowledge typically from advanced education.
• Baccalaureate degree required.
• Experience in regulatory affairs via internship, preferably in medical devices.

Responsibilities

• Directs or coordinates document packages for regulatory submissions.
• Leads submission materials for licenses, renewals and registrations.
• Recommends changes for labeling, manufacturing and clinical protocols for compliance.
• Prepare regulatory submissions for product changes to ensure timely approvals.
• Interact with regulatory agencies on projects at reviewer level.

Skills

Regulatory knowledge

Education

Baccalaureate 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

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.

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. 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.