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

MAIN PURPOSE OF JOB

• Reporting to the Manager, Post-Market Vigilance, the Associate Post-Market Vigilance Specialist, has demonstrated adequate technical experience for completing all activities related to the processing of incoming Product Complaints and Regulatory Reporting activities. The Associate Specialist is expected, when required, to partner globally within Medtronic to continually support efficient and effective complaint handling/recall processes across the Canada region and the Medtronic Operating Units (OU). This position is responsible for supporting the Manager in meeting Quality Objectives to ensure proper synchronization of workflow across the entire post-market vigilance value stream. This position will also support the Manager in ensuring consistency with applicable Regulations, Policies, Procedures and Work Instructions.

This is a 1 year contract position to cover a leave in our Brampton, Ontario office.

MAIN JOB DUTIES/RESPONSIBILITIES (may include the following and other duties may be assigned):

• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.

• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.

• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

• Responsible for reporting complaints and Adverse Drug Reactions (ADR)

• Supports the company's cell/tissue/organ (CTO), drug, and medical device post-market vigilance (PMV) programs including all complaint handling, regulatory reporting and, when required, recall activities in compliance with government regulations.

• Work independently, collaboratively or in support of the OU/Customer Quality Experience Management in the following complaint handling and recall activities (as applicable and not limited to):

• Event Intake, Assessment, and Complaint Determination

• Communications (Follow Up, Letters of Analysis, Translation)

• Review of Investigation/Analysis findings conducted by the Manufacturer

• Reportability Decisions

• Regulatory Reporting and Regulatory Inquiries

• Works collaboratively with internal stakeholders and, with support of the Post-Market Vigilance Manager, external stakeholders, including but not limited to Regulatory Authorities, Original Equipment Manufacturers (OEM), Distributors, Suppliers and Third-Party Logistics partners in completing the complaint handling and regulatory reporting activities above.

• Is responsible for complete and accurate maintenance and reporting of Mandatory Medical Devices Problem Reporting (MDPR) / Error, Accident, Adverse Reactions / Adverse Drug Reaction (ADR) data or adverse reaction data as required by Health Canada.

• Identifies and participates in continual process improvement projects related to applicable PMV processes.

• Supports the education of and partners with other organizational team members to improve process workflow, develop tools or support system enhancements in alignment with Health Canada requirements.

• Supports the Manager in the documentation review and approval of CAPAs and Deviations reporting in response to procedural or regulatory commitments.

• Supports the investigation and response to requests from internal stakeholders and external customers (including Health Canada) related to product performance issues, holds and recalls in a timely fashion.

• Maintains current knowledge on regulatory requirements and ensure compliance with local and corporate quality management system requirements.

• Perform additional related duties as required.

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, 0 years of experience required.

REQUIRED QUALIFICATIONS
KNOWLEDGE/EDUCATION

• Bachelor’s degree in a Science, Biomedical Engineering, or related field

JOB EXPERIENCE

• No minimum years of relevant experience

SKILLS/COMPETENCIES

• Adequate understanding of Health Canada regulations for medical device, CTO and drug products regarding Complaint Handling, Incident Reporting/Error, Accident, Adverse Reactions/Adverse Drug Reaction (ADR) reporting;
• Sufficient project management skills (planning and estimating phases, work and task breakdown structures, set milestones, remove barriers to meet milestones);
• Ability to handle multiple priorities and effectively manage personal time in a fast-paced environment;
• Ability to work independently with regular supervision.
• Excellent analytical, and verbal/written communication skills.
• Bilingual in both English and French is preferred.

DESIRED/PREFERRED QUALIFICATIONS
KNOWLEDGE/EDUCATION

• Advanced degree or significant relevant experience

JOB EXPERIENCE

• Minimum of 2 years relevant experience

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.

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.