Senior Regulatory Affairs Specialist

Must Have: Minimum Requirements

• Bachelor’s degree
• Minimum 4 years of experience in medical device regulatory affairs 
• OR minimum 2 years of experience in medical device regulatory affairs, and an advanced degree
• Experience working with medical device or pharmaceutical regulatory submissions

Nice to Have

• 7+ years medical device industry experience
• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and TUV), and working with cross-functional project teams           
• Experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Experience with Class II/III medical devices (510(k), PMA, IDE)
• Experience with drug/device interaction test requirements/data
• Experience with working with pharmaceutical companies
• Experience with software development and cybersecurity applications
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills
• Ability to effectively manage multiple projects and priorities
• Proficient computer skills
• Experience performing advertising and promotion reviews for medical devices
• Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
• Project management skills
• Effective interpersonal skills
• Effective team member
• Clinical or statistical experience
• Medtronic product development experience

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)