Principal Regulatory Affairs Specialist - Cybersecurity

Must Have: Minimum Requirements
 

• Bachelors degree required
• Minimum of 7 years of medical device regulatory experience or cybersecurity experience within a regulated industry
• Or advanced degree with a minimum of 5 years medical device regulatory experience or cybersecurity experience within a regulated industry

 

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

•  Bachelor’s Degree
• Minimum of 7 years of medical device regulatory experience, or an advanced degree with a minimum of 5 years of medical device regulatory experience.

Nice to Have  

• Experience in Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier, including IDE and software-containing devices.
• Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
• Software-related regulatory experience required (e.g., IEC62304, FDA Software/ Cybersecurity Guidance Documents)
• Ability to establish the framework for compliance with cybersecurity regulations, including internal/external audit experience
• Prior experience with software-driven devices
• Familiarity with regulatory requirements in major international markets
• Experience working with privacy regulations
• Good understanding of product development process and design control through knowledge of US FDA and International medical device regulations.
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations
• Ability to compile data and summarize results
• Proficiency in FDA compliance.
• Organized, efficient, process-oriented; high attention to detail
• Effective interpersonal communication skills
• Works well under pressure in a dynamic timeline-driven environment
• Ability to effectively manage and lead multiple projects and priorities
• Demonstrate skill sets in Microsoft Word, Excel, Office, PowerPoint, and Adobe software 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)