Sr Regulatory Affairs Specialist - 3 months Contract at Medtronic

Brampton, Ontario, Canada

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

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

Responsibilities

Prepare, submit and manage applications for regulated medical products (i.e. Drugs, Devices, CTO, Others) to meet the regulated agency requirements and ensure followup 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)
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 de

Skills

Key technologies and capabilities for this role

Regulatory AffairsMedical DevicesProduct RegistrationHealth CanadaGTS BlocksRACsMDELDELCTOQuality Management SystemPromotional Material ReviewLicense Renewals

Questions & Answers

Common questions about this position

Is this a remote position or does it require office presence?

This information is not specified in the job description.

What is the salary or compensation for this Sr Regulatory Affairs Specialist role?

This information is not specified in the job description.

What are the key responsibilities and skills needed for this role?

Key responsibilities include preparing and submitting regulatory applications for medical products, acting as Strategic Regulatory Lead for a local Business Group, interfacing with regulatory bodies like the Medical Devices Bureau, ensuring compliance, managing RACs, GTS blocks, and supporting RFPs and tenders.

What is the company culture like at Medtronic?

Medtronic emphasizes a life-long career of exploration and innovation, leading with purpose to champion healthcare access and equity, while breaking down barriers to innovation in a connected, compassionate world.

What makes a strong candidate for this position?

Strong candidates will have expertise in regulatory affairs for medical devices, drugs, and other products in Canada, experience interfacing with Health Canada and regulatory bodies, and skills in managing submissions, compliance, RACs, and cross-functional coordination.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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