Wednesday , February 28 2024

Medtronic Canada Careers – Sr Regulatory Affairs Specialist

Website Medtronic

Job Description:

This position has a focus on the regulatory process for the licensing of products sold by Medtronic in Canada with the additional responsibilities of ensuring our internal Medtronic of Canada Quality System is followed and remains robust.

Job Responsibilities:

  • Ensure regulatory compliance.
  • Responsible for reporting complaints and Adverse Drug Reactions (ADR)
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • 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.).
  • Keeps abreast of regulatory procedures and changes.
  • Strategic Regulatory Lead for a local Business Group to ensure timely market access and maintenance through products registration, well aligned with the market strategies.
  • Represent Medtronic of Canada objectives/requirements with Global Partners.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Responsible for defined portfolio, gap analysis, development of strategic plans to grow the business, mitigate risk, resolve deficiencies and technical issues.
  • Monitors and improves tracking / control systems.
  • Regulatory responsible contact and member of Business Unit Leadership team/meetings, to address business challenges, development of long-range planning within the regulatory context.
  • Recommends strategies for earliest possible approvals of clinical trials applications.
  • 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.
  • May direct interaction with regulatory agencies on defined matters.
  • 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.
  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Job Requirements:

  • Demonstrated organizational abilities.
  • Effective at influencing and building strong working relationships across all levels.
  • Bachelor’s degree in Life Sciences
  • Knowledge of medical device products and therapies.
  • Direct experience negotiating/working with Health Canada representatives to meet business objectives while ensuring safety/efficacy.
  • Professional Relationships (Health Canada, Associations).
  • Demonstrated leadership competencies.
  • Knowledge of TPD Ottawa Bureau.
  • Proven experience with drug and device regulatory/submission process.
  • Experience with interacting with Regulatory Agencies.
  • Minimum of 4 years of relevant experience in Regulatory Affairs.
  • 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.
  • Demonstrated Strong Business Acumen.
  • Advanced degree (M.Sc. or Ph.D.).
  • Minimum of 2 years relevant experience inR&D experience
  • International experience.
  • French communication skills are beneficial.
  • Technology Expertise in software as a medical device / artificial intelligence.

Job Details:

Company:  Medtronic

Vacancy Type:  Full Time

Job Location: Toronto, CA

Application Deadline: N/A

Apply Here

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