Regulatory Affairs Specialist

Key Skills

Aartificial intelligence, Data science techniques, Design, Effective communication skills, Leadership Skill, Planning and organization, Teamwork

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 coordinates the planning, preparation, assembly, review, and publication of document packages for regulatory submissions from all company areas, internal audits, and inspections.
• Writes regulatory justifications to support submission filing decisions.
• Leads or compiles all materials required in submissions, license renewal, and annual registrations.
• Ensures regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
• Interact with regulatory authorities during the development and review process to ensure submission approval.
• Participates as RA Representative on project teams with members of development project teams as necessary to communicate regulatory submissions requirements and preparations according to a defined timeline.
• Recommends labeling, manufacturing, marketing, and clinical protocol changes for regulatory compliance.
• Review and approve ECNs, PCNs, NCRs, product labeling, and promotional materials, per company procedures, to assure compliance with regulatory requirements. 
• Keeps abreast of regulatory procedures and changes.
• Maintain current knowledge of the development and changes to applicable laws, regulations, and industry standards, and assist in disseminating this information to the appropriate individuals within the company. 
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. 
• Recommends strategies for earliest possible approvals of clinical trial applications.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of regulatory affairs experience.

Nice to Have

• Understanding of engineering concepts and scientific terminology
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationale
• Experience reviewing technical and design specifications
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Superior interpersonal skills
• Excellent analytical thinking skills
• Ability to effectively manage multiple projects and priorities
• Proven ability to work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Strong organization and time management skills
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• Some overnight travel required

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.