Senior Regulatory Affairs Specialist

Key Skills

Aartificial intelligence, AI Robotic systems, Data science techniques, Neuroscience, Project management, Teamwork, Writing

Job Description

Part of the Neuroscience portfolio, Cranial and Spinal Technologies (CST) is redefining cranial and spinal procedures to reduce variability and improve outcomes with the goal of restoring long-term quality of life for more patients. CST is comprised of four global businesses: Spine & Biologics, Enabling Technologies, intelligent Data Solutions (iDS), and China Cranial, Spinal, Orthopedics & Technologies.

• Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion.
• Enabling Technologies, delivers an innovative portfolio which include robotics, navigation, intra-operative imaging, advanced energy devices, cerebral spinal fluid management and critical care. 
• intelligent Data Solutions (iDS), with Medicrea as the foundation, is revolutionizing the standard of care for personalized spine surgery using data science and Artificial Intelligence (AI) so all spine surgeons can provide predictable and reproducible patient outcomes.
• China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

A Day in the Life

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 company areas, 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 trial applications.

Must Have: Minimum Requirements

• Bachelors degree in engineering, physical/biological, or health sciences required
• Minimum of 4 years of regulatory affairs experience or advanced degree with a minimum of 2 years of experience

Nice to Have

• Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences).
• Proficiency in assessing changes to labeling, design, materials, and manufacturing for impact on US and EU requirements.
• Experience with 510(k)/IDE/PMA device product submissions and EU regulations (MDR
• Experience performing advertising and promotion reviews for medical devices.
• Experience with FDA and international regulatory agency requirements
• Effective interpersonal skills.
• Effective team member.
• Ability to comprehend engineering, physiology, and medical device use principles. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient computer skills.
• Project management skills.
• Excellent oral and written skills.
• Excellent analytical thinking skills.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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 and co-workers. 

A commitment to our employees' lives is 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. Learn more about our benefits here.