We anticipate the application window for this opening will close on - 23 May 2025

 

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

A Day in the Life

The Principal Regulatory Affairs Specialist will have a role in supporting product teams for new/updated Class I, II, and III devices across 2 operating units with varying products and business needs.  Collaboration with cross function teams (e.g., R&D, Clinical, Quality, Marketing, etc.) to ensure global requirements and strategies are incorporated into the project documentation will be a key deliverable for this role and will be measured by submission ready outputs for inclusion in global submissions.  Additionally, this role will support the Total Product Lifecyle (TPLC) for capital equipment, disposable/sterile surgical tools, and CSF/critical care related devices across the cranial and spine space.

The Principal Regulatory Affairs Specialist will be responsible for compliance with US and EU regulatory requirements and partner with international Medtronic regulatory teams to ensure awareness of requirements and appropriate outputs to support global regulatory submissions.  This role will have responsibility for documenting US and EU regulatory decisions, agency submissions, and ensuring documentation is maintained to current regulatory requirements.  This responsibility may include supporting internal audits and agency inspections.

It will be the Principal Regulatory Specialist’s responsibility to ensure senior management is informed of the regulatory status of products, regulatory issues, and regulatory compliance. 

The successful candidate will be able to work well with advanced regulatory concepts and undefined pathways.  Additionally, they will be able to work independently, develop robust regulatory strategies and work collaboratively across the organizational matrix.

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

• Collaborate with product teams to ensure global requirements and strategies have been incorporated into the project deliverables resulting in submission ready outputs.
• Develop and support global regulatory strategies for Class I, II, and III devices/accessories across 2 operating units with varying business needs.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
• Leads or compiles all materials required in submissions, license renewal, and annual registrations.
• Ensures product complies with global regulatory requirements as part of the TPLC.  This may include recommending changes for labeling, manufacturing, marketing, and clinical protocol.
• Monitors and improves tracking/control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

Qualifications

Must-Have: Minimum Requirements

• Requires a minimum of 7 years of regulatory affairs experience, or advanced degree with a minimum of 5 years of experience.

Nice to Have:

• At least 5 years’ experience working with and solid understanding of the Design History File and how it ties to regulatory submission documents.  This includes working with product development teams to bring a new/updated product to market.
• Experience working in a corporate environment and an understanding of how to navigate a matrix organization.
• Ability to critically think about problems/questions as well as collaborate with others with diverse perspectives to identify and drive to solutions.
• Ability to provide mentorship to more junior team members to assist them in critically thinking about problems/questions.

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. 

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