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

This position is an exciting opportunity to work with Medtronics Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential enabling us to operate with greater speed and agility. As a separate entity we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

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

• 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.
• Define the regulatory strategy and manage regulatory submission activities forproduct maintenance for existing approved products.
• Prepare regulatory (e.g. Health Canada) submissions for product changes asrequired to ensure timely approvals for market release.
• Provide support to currently marketed products as necessary. This includes reviewinglabeling promotional material product changes and documentation for changesrequiring government approval.
• Support regulatory compliance activities including manufacturing site registrationaudits etc. as needed.
• Ensure all regulatory activities involving the importation and distribution of medical devices in Canada are in compliance with the regulations.
• Ensure all regulatory records are properly/accurately and adequately maintained in accordance with regulatory requirements and internal processes.
• Provide business and product information to international regulatory team to enabledevelopment of strategies and requirements and communicate that information tobusiness teams.
• Ensure personal understanding of all quality policy/system items that are personallyapplicable.
• Follow all work/quality procedures to ensure quality system compliance and high quality work.

SALARY RANGE: $88000 - $110000

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.

PLEASE NOTE:

• We use artificial intelligence (AI) to review resumes of candidates and assess their fit based on the criteria outlined in the job posting. We do not use AI to make any final hiring or interview decisions.

• This posting reflects a current genuine vacancy that we are actively recruiting to fill.

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