At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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

• Prepare submit and manage applications for regulated medical products (i.e. DrugsDevices 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 accessand maintenance through products registration well aligned with the marketstrategies.
  Drive/Lead meetings and interface with the Medical Devices Bureau and otherpertinent regulatory bodies (for drug natural health products and biologic productstelecommunication products etc.).
  Represent Medtronic of Canada objectives/requirements with Global Partners
  Ensure regulatory compliance.
  Ensure compliance with Medtronic and Medtronic of Canada Quality ManagementSystem 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 additionalinformation
  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 medicaldevices natural health products and drugs are in compliance with their respectiveregulations
  Participate in Quality and Regulatory compliance initiates including writing and/orrevising Standard Operating Procedures for Work Instructions.
  Provide support for Tenders RFPs and customer requests
  Ensure all regulatory records are properly and adequately maintained in accordancewith regulatory requirements and internal processes.

MAIN JOB DUTIES/RESPONSIBILITIES (may include the following and other duties maybe assigned):
Directs or performs coordination and preparation of document packages for regulatorysubmissions from all areas of company internal audits and inspections.
Leads or compiles all materials required in submissions license renewal and annualregistrations.
Recommends changes for labeling manufacturing marketing and clinical protocol forregulatory 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/Drugproducts Food and Drug Act and Regulations and Natural Health products
Regulations.
Familiarity with ISO13485:2003 Medical Devices Quality Management Systems andMedtronic of Canada.
Regulatory responsible contact and member of Business Unit Leadership
team/meetings to address business challenges development of long range planningwithin the regulatory context.

Responsible for defined portfolio gap analysis development of strategic plans to growthe business mitigate risk resolve deficiencies and technical issues.
Develops the Canadian regulatory licensing strategy. Identifies required elements foreach submission and/or long range plans in collaboration with Medtronic of CanadaMarketing Manager(s) or Divisional Director(s) with the objective to accelerate marketaccess and negotiate with regulator when required.
Negotiate prioritization/plan with BU for submissions according to BU and Medtronicof Canada Divisional product strategies.
Ensure proper elements of product submissions are collected from BUs prepared andsubmitted in a timely manner.
Leadership with Agencies in area of expertise and portfolio responsibility.
Organizes agency meetings in support of Medtronic product development goals andobjectives.
Advocate/influence with global partners as required to support local strategies.
Accountable for assessing coordinating and compiling deficiency responses in a timelymanner.
Collaborate with the Regulatory Team Regulatory Officers as well as OperationsManagement to innovatively address regulatory issues and support achievement ofRegulatory Compliance.
Implement new and proposed regulations and guidelines published by governmentalregulatory authorities as they apply to Medtronic products.
Participate in Quality and Regulatory compliance initiatives including writing and/orrevising Standard Operating Procedures.
Ensure all regulatory records are properly and adequately maintained in accordancewith regulatory requirements and internal processes.

KNOWLEDGE/EDUCATION
Bachelors degree in Life Sciences
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 andOrgans for Transplantation Regulations

JOB EXPERIENCE
Minimum of 4 years of relevant experience in Regulatory Affairs.
Proven experience with drug and device regulatory/submission process.
Regulatory Agency experience.
Business Development.
Direct experience negotiating/working with Health Canada representatives to meetbusiness objectives while ensuring safety/efficacy.
SKILLS/COMPETENCIES
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.

DESIRED/PREFERRED QUALIFICATIONS
KNOWLEDGE/EDUCATION
Advanced degree (. or Ph.D.).
JOB EXPERIENCE
Minimum of 2 years relevant experience in R&D experience.

SKILLS/COMPETENCIES
International experience.
French communication skills.

SPECIALIST 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:Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact:May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties .
Makes improvements of processes systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence:Communicates with senior internal and external customers and vendors.
Exchange information of facts statuses ideas and issues to achieve objective and influence decision-making.

Leadership and Talent Management:May provide guidance coaching and training to other employees within job area.
May manage projects requiring delegation of work and review of others work product .

Required Knowledge and Experience:Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience.
May have practical knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.

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 95000 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.

Learn more about our business mission and our commitment to diversity here