Senior Regulatory Affairs Specialist

Must Have: Minimum Requirements

• Bachelor’s Degree
• Minimum 4 years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
• Minimum 2 years of regulatory experience in medical device, biotech, or pharmaceutical industry with an advanced degree.

Nice To Have

 

• Bachelor’s in Engineering, Science, Regulatory Affairs
• Master’s Degree in Regulatory Science
• Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, drug or biologics submissions)
• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances. 
• Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews
• Experience with regulatory support of clinical trials
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
• Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements
• Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports. IVD device experience is preferred.
• Regulatory Affairs Certification (RAC)
• Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
• Ability to compile data and summarize results
• 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 multiple projects and priorities
• Demonstrated 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)