Regulatory Affairs Specialist

• Bachelors degree required and a minimum of 2 years of experience in regulatory affaris, medical device or quality, or advanced degree with 0 years of experience in regulatory affairs, medical device or quality

Nice to Have (Preferred Qualifications):

• At least 2-3 years regulatory submission experience.
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Experience with international standards (ISO, GHTF, ICH).
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
• Experience with FDA and international regulatory agency requirements, CE marking (AIMD and MDD).
• Experience with medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device).
• Experience working with cross-functional teams.
• Experience working with technical documentation.
• Project management skills.
• Product development experience.
• Knowledge of Medtronic procedures and systems.
• Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.

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)