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

This position is located in Lafayette, CO as part of the Acute Care & Monitoring (ACM) group.

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ pulse oximetry monitoring and digital solutions HealthCast™ VitalSync™ remote patient monitoring product portfolios within the Acute Care and Monitoring operation unit. This role is fit for a productive individual contributor who works independently on moderately to highly complex projects or programs with limited general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You will also participate in cross-functional activities, requiring awareness of wider organizational issues.
The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. The initial project scope for this employee will be related to regulatory sustaining activities.

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 and compiles all materials required for US and EU submissions and tenders, including 510(k) submissions, NB sampling, and EU MDR Technical Documentation.
• Supports submissions and inquiries for global markets.
• Collaborates closely with cross-functional partners such as R&D, clinical, operations, and marketing to establish regulatory value and ensure regulatory requirements and strategy are integrated into product development and lifecycle management.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Reviews promotional material.
• Monitors, updates, and improves project tracking and US/EU distribution control systems.
• Proactively monitor and interpret evolving global regulatory requirements and communicate potential impact to stakeholders.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible path to market.
• Support internal and external audits/inspections, including serving as a functional lead.
• Develop and deliver training on regulatory requirements and changes to cross-functional teams.
• Mentor junior regulatory staff or provide onboarding support.
• Participate in CAPA investigations when regulatory issues are identified
• NPD activities may be tied into the role later on.

Must Have: Minimum Requirements

• Bachelor’s degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

Nice to Have
 

• Experience in medical device regulatory
• Strong experience with class I and II electrical and software-based devices including applicable standards.
• Strong knowledge of EU MDR, ISO 10993-1, ISO 13485, and ISO 14971 risk management principles.
• Experience with regulatory requirements for cybersecurity, AI, and communicating devices (interoperability).
• Proven experience authoring and leading 510(k) submissions and EU Change Notifications.
• Strong experience compiling MDR Technical Documentation.
• Experience communicating directly with regulators.
• Collaborative, solution-oriented performer focused on bringing value to stakeholders and the organization
• Proven ability to develop and execute on robust regulatory strategies.
• Strong experience reviewing promotional materials for US/EU markets.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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