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Sr. Regulatory Affairs Specialist

Regulatory Affairs
220000KX Requisition #

Careers that Change Lives

Our space, the medical device and healthcare industry, is rapidly changing.  It always has been that way.  With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success.  Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

A Day in the Life

This position has a focus on the regulatory process accountable for providing high quality technical/administrative support as required in assessing product changes (RACs), managing and clearing GTS Blocks, supporting RFPs and Tenders, responding to regulatory queries, and promotional material reviews.

  • Prepare, submit and manage applications for regulated medical products (i.e. Drugs, Devices, CTO, Others) to meet the regulated agency requirements and ensure follow-up until approval.
  • Strategic Regulatory Lead for a local Business Group to ensure timely market access and maintenance through products registration, well aligned with the market strategies.
  • Drive/Lead meetings and interface with the Medical Devices Bureau and other pertinent regulatory bodies (for drug, natural health products and biologic products, telecommunication products etc.).
  • Represent Medtronic of Canada objectives/requirements with Global Partners
  • Ensure regulatory compliance.
  • Ensure compliance with Medtronic and Medtronic of Canada Quality Management System, policies, procedures and work processes.
  • Ensure regulatory activities are performed to established schedules and budgets.
  • Liaise with Operating Units to respond to RACs in a timely manner
  • Review and assess RACs to ensure compliance with Canadian Regulations
  • Respond to Health Canada, Physician, and Field Personnel request for additional information
  • Manage and resolve GTS blocks and regulatory queries.
  • Assist in managing annual license renewals (MDEL/DEL/CTO)
  • Manage and actively participate in Enterprise and local initiates for all products licensed for sale in Canada to ensure accuracy of information
  • Ensure all regulatory activities involving the importation and distribution of medical devices, natural health products and drugs are in compliance with their respective regulations
  • Participate in Quality and Regulatory compliance initiates including writing and/or revising Standard Operating Procedures for Work Instructions.
  • Provide support for Tenders, RFPs and customer requests
  • Ensure all regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes
  • 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 clinical trials applications.
  • Responsible for reporting complaints and Adverse Drug Reactions (ADR)
  • Maintain up-to-date knowledge of Canadian Medical Devices Regulations and Guidelines for licensing of Medical Devices and combination Medical Device/Drug products, Food and Drug Act and Regulations, and Natural Health products Regulations.
  • Familiarity with ISO13485:2003 “Medical Devices – Quality Management Systems” and Medtronic of Canada.
  • Regulatory responsible contact and member of Business Unit Leadership team/meetings, to address business challenges, development of long range planning within the regulatory context.
  • Responsible for defined portfolio, gap analysis, development of strategic plans to grow the business, mitigate risk, resolve deficiencies and technical issues.
  • Develops the Canadian regulatory licensing strategy. Identifies required elements for each submission and/or long range plans in collaboration with Medtronic of Canada Marketing Manager(s) or Divisional Director(s), with the objective to accelerate market access and negotiate with regulator when required.
  • Negotiate prioritization/plan with BU for submissions according to BU and Medtronic of Canada Divisional product strategies.
  • Ensure proper elements of product submissions are collected from BU’s, prepared, and submitted in a timely manner.
  • Leadership with Agencies in area of expertise and portfolio responsibility.
  • Organizes agency meetings in support of Medtronic product development, goals and objectives.
  • Advocate/influence with global partners as required to support local strategies.
  • Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.
  • Collaborate with the Regulatory Team, Regulatory Officers as well as Operations Management to innovatively address regulatory issues and support achievement of Regulatory Compliance.
  • Implement new and proposed regulations and guidelines published by governmental regulatory authorities as they apply to Medtronic products.
  • Participate in Quality and Regulatory compliance initiatives including writing and/or revising Standard Operating Procedures.
  • Ensure all regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes.
Must Have: Minimum Requirements
  • Bachelors degree in Life Sciences required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • Knowledge of products and therapies.
  • Knowledge of TPD Ottawa Bureau.
  • Professional Relationships (Health Canada, Associations).
  • Knowledge of Canadian Medical Device Regulations, ISO Medical Device Standards (13485:2003). Food and Drug Act and Regulations, Safety of Human Cells, Tissues and Organs for Transplantation Regulations.
  • Proven experience with drug and device regulatory/submission process.
  • Regulatory Agency experience.
  • Direct experience negotiating/working with Health Canada representatives to meet business objectives while ensuring safety/efficacy.

Nice to Have
  • Advanced degree (M.Sc. or Ph.D.).
  • Minimum of 2 years relevant experience in R&D experience
  • Demonstrated leadership competencies.
  • Effective at influencing and building strong working relationships across all levels.
  • Negotiation Skills.
  • Technology Expertise.
  • Business Acumen.
  • Demonstrated organizational abilities.
  • Good Communication skills.
  • Excellent Computer Skills.
  • Medtronic Competencies.
  • Strong interpersonal and communication skills at all levels of the organization.
  • Proven track record of good judgment.
  • Demonstrated integrity and respect for all.
  • Attention to detail.
  • Strong problem solving and results driver.
  • Ability to manage multiple priorities in a fast-paced environment.

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. Let’s 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. 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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