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Specialist, Post-Market Vigilance and Compliance (12 - 18-month contracts)

Brampton, ON L6V 3H3
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Specialist, Post-Market Vigilance and Compliance (12 - 18-month contracts)


Brampton, Ontario, Canada

Requisition #:


Post Date:

Sep 02, 2019

**Careers that Change Lives**

**Bring your talents to a leader in medical technology and healthcare solutions.** **Rooted in our long history of mission-driven innovation, our medical technologies** **open doors.** **We support your growth with the training, mentorship, and guidance you need to own your future success.** **Join us for a career that changes lives.**

**A Day in the Life**

Reporting to the Supervisor, Post-Market Vigilance, the Specialist has the primary responsibility for completing all activities related to the processing of incoming product complaints to ensure that all product performance issues related to the quality, identity, reliability, safety and effectiveness of products are captured, investigated and responded to efficiently via regulatory reports within required regulatory timelines. This position is responsible for meeting department-wide Quality objectives and participate in corporate and local improvement processes to ensure consistency with applicable Regulations, Policies, SOPs, and work instructions. Other regulatory or liaison activities may also be assigned.

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

+ Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.

+ Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.

+ Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.

+ May counsel stakeholders about these requirements as necessary.

+ Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.

+ Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.

+ Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

+ Receives and documents product events reported by customers and field representatives.

+ Requests additional information as needed for complete understanding of the event.

+ Assesses events for regulatory reportability and potential impact to patient safety and business Operations.

+ Provides technical expertise and assistance in handling complaints to comply with the current Health Canada reporting regulations.

+ Completes and submits regulatory reports within the timeframes mandated by Health Canada.

+ Executes follow-ups to obtain missing information in collaboration with cross-functional partners.

+ Uses good documentation practices to record all information related to the events into the complaint databases.

+ Maintains files that meet the Quality Management System and corporate requirements and ensures record documentation is maintained in a constant state of audit readiness per internal policies.

+ Uses and maintains database(s), provide analysis and data trends on all complaints.

+ Participates and/or presents data trends and reporting during periodic review meetings.

+ Develops internal systems, methods, and procedures to maintain compliance and support post- market surveillance.

+ Participates in multi-business teams to evaluate and make recommendations to system changes/upgrades.

+ Maintains enhanced technical knowledge of devices in area of responsibility.

+ Educates and trains internal stakeholders on the proper method of reporting complaints.

+ Participates in continued process improvement of the complaint handling and regulatory reporting processes, including periodic audit and assessment of the function.

+ Evaluates, develops and recommends solutions to complex problems and issues as required.

+ Participates in the documentation review and approval of CAPAs and Deviations reporting in response to procedural or regulatory commitments.

+ Coordinates and provides direction and support multiple groups in the effort to complete multifaceted tasks associated with complaint handling, corporate quality holds and recalls when required.

+ Investigates and responds to requests from internal stakeholders and external customers (including Health Canada) related to product performance issues, holds and recalls are performed in a timely fashion.

+ Contributes to the management of corporate quality holds and recalls from inception until final disposition and closure of the hold file with the Business Units, Distribution Centers and Third Party Logistics including regular follow-up with Regulatory Agencies and internal contacts until closure of the recall file.

+ Partners and coordinates work with upstream and downstream organizations to ensure compliance with all applicable processes and goals across the value stream

+ Leads special QARA projects and assignments as required.

+ Responsible for reporting complaints and Adverse Drug Reactions (ADR).

**Must Have: Minimum Requirements**

+ A Bachelors degree is required.

+ Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

+ Excellent analytical and communication skills.

+ Ability to work independently with minimal supervision and multi task.

+ Strong knowledge on the use of products, the environment of use and able to discern if issue is reportable to Health Canada based on Health Canada regulation.

+ Strong knowledge of Quality Management System and Regulatory Affairs concepts and processes.

+ Excellent understanding of the use of a wide range of medical devices and drugs.

+ Solid understanding of Health Canada regulations for Medical Devices and Drugs regarding Complaint Handling/Mandatory Problem Reporting (MDR)/Adverse Drug Reaction (ADR) reporting and Recalls (basic understanding of International regulations).

+ Excellent typing skills, computer literate (Word, Excel, Powerpoint etc).

+ Bilingual in both English and French is preferred.

+ Thorough understanding of ISO 13485 requirements, Good Manufacturing Practices (GMP) for Drugs.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

**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. 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._
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.


Jobs Rated Reports for Compliance Officer

Posted: 2019-09-05 Expires: 2019-10-12

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Specialist, Post-Market Vigilance and Compliance (12 - 18-month contracts)

Brampton, ON L6V 3H3

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Compliance Officer
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Median Salary: $67,870

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