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Principal Regulatory Affairs Engineer

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Regulatory Affairs
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180003PJ Requisition #
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Principal Regulatory Affairs Specialist

 

Careers That Change Lives

 

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. 

MITG's SURGICAL ROBOTICS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services.

 

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Come strengthen your specialized skills and enhance your expertise.  We’ll help you to expand your expertise with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you. Together, we can confront the challenges that will change the face of healthcare.

 

As Principal Regulatory Engineer, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory authorities. You must have a track-record of working effectively with teams and developing innovative regulatory strategies for novel electromechanical medical devices.

 

 

A Day in the Life

 

The Principal Regulatory Engineer is expected to perform with minimal supervision and is responsible for influencing department processes and procedures, developing regulatory submission, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. In addition, the Principal Regulatory Engineer mentors other regulatory colleagues, provides support for global regulatory submissions, and ensures compliance with Medtronic and government requirements. Your focus will be:

  • Prepare and maintain US, EU, and international submissions (or critical parts thereof) for new product and changes to existing product to ensure timely approvals of clinical studies and marketing authorization. Specifically,
    • 510(k) for initial product, expanding indications for use, and design changes in accordance with 21 CFR Part 807
    • EU Technical Document in accordance with Regulation (EU) 2017/745 and 2006/42/EC
    • US Investigational device exemption (IDE) in accordance with 21 CFR Part 812
    • US Pre-submissions
  • Negotiate submission requests/issues with agency personnel.
  • Develop global regulatory strategies. Ensure strategy outputs are properly communicated to development teams and business. Specifically,
    • Device classification
    • Identification of all potentially applicable rules and government expectations
    • Global registration timelines
    • EU GSPR and MDSAP list of Essential Principles, including list of critical standards
  • Support product development by guiding teams on complex regulatory issues, including reviewing scientific/engineering material (protocols/reports), interpretation of standards, regulations, and guidance documents. Specifically,
    • Software life-cycle and cybersecurity
    • Quality management system
    • Medical electrical equipment, including systems
    • Human factors and usability
    • Risk management
    • Preclinical (animal) studies
    • Sterilization and biocompatibility, including reusable/resterilizable devices
    • Pre- and post-market clinical studies, including IDE, PMCF, CEP
    • “Valid scientific evidence” and “substantial equivalence” topics
  • Support international regulatory submissions by providing timely documents as requested throughout the submission process.
  • Support market-released products, as necessary. This includes reviewing most changes affecting outputs of design controls.
  • Assist quality management system audits, including regulatory parts of MDSAP and EU.
  • Review/approve and guide the development of advertising and promotional material.
  • Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel.

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.

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.