Principal Regulatory Affairs Engineer

Must Have: Minimum Requirements

• Bachelor’s Degree in engineering discipline
• Minimum 9 years medical device industry experience with at least 5 years in a regulatory role involving electromechanical (including software) devices.
• Minimum US Class II and EU Class IIb device experience and in-depth knowledge of US FDA regulations (Title 21) and EU CE Marking directives.
• History of successful US 510(k) submissions, Q-submissions, EU technical files
• In-depth knowledge of preclinical and clinical study rules/regulations.
• Negotiation skills
• Excellent written/oral communication skills.
• Thorough knowledge of other regulations pertaining to the commercialization of medical devices.
• Thorough/Working knowledge of MDSAP and EU. Specifically,
  • US Quality System Regulation, Canadian Medical Device Regulation, EU Medical Device Directive or Regulation (EU) 2017/745, and ISO 13485:2016.

Nice to Have 

• Advanced Degree
• RAC certification(s)
• Experience with US Class III device submissions, including IDE
• Regulatory Compliance competency (Inspections, Audits, Field Actions)
• International Regulatory submissions experience
• Clinical Trial experience

Location

The position is based in Boston, MA

PHYSICAL 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. 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.

ABOUT MEDTRONIC

Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology 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 can 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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law.  In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:  http://www.uscis.gov/e-verify/employees

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.