Job Description

SENIOR REGULATORY AFFAIRS SPECIALIST - SURGICAL ROBOTICS

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.

In the Surgical Robotics (SR) business, part of Medtronic’s Medical Surgical Portfolio, we believe patients around the world deserve access to quality care and improved outcomes. We strive to expand global access to care and reduce variability through robotic and analytics solutions.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

The preference is for this position to be based in Boston, MA or North Haven, CT but a remote assignment may be considered within the U.S. 

Careers That Change Lives

The Senior Regulatory Affairs Specialist will play a key role in expanding indications and sustaining the current product portfolio.  As a core team member, the senior specialist works directly with the team from the concept phase through commercialization.  The senior specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support development of regulatory strategy worldwide.  Sustaining regulatory responsibilities include reviewing changes to current portfolio and documenting assessments, supporting updates to technical files or preparing submissions in US or EU as applicable (e.g. IDE, 510k, DeNovo, Change notification, etc), reviewing promotional materials, and ensuring that our product technical documentation is current and accurate.  

From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company.

A Day In The Life

Provide strategic input and technical guidance on regulatory requirements for expanding indications and product modifications, considering both domestic and international regulations
Prepare regulatory (eg, FDA/Notified Body) submissions for expansion of indications and product changes, as required, to ensure timely approvals for clinical trials or market release. 
May direct interaction with regulatory agencies on defined matters.
Maintenance and update of Technical files as appropriate for product changes to meet EU MDR and UKCA requirements
Support international product registrations as needed
Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Participate in internal and external audits as needed
Keeps abreast of regulatory procedures and changes.
Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
Perform other duties as assigned or required

Must Have: Minimum Requirements

Bachelor’s degree with 4 years of medical device regulatory affairs or related experience
OR an advanced degree with 2 years of medical device regulatory affairs or related experience

Nice to Have

Experience in drafting US and EU submissions that include Pre-Sub, IDE, 510(k), and Technical File/Design Dossier
Prior direct involvement with product development teams
Familiarity with regulatory requirements in major international markets
Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs
Working knowledge of IEC 60601-series standard
Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.
Ability to compile data and summarize results
Proficiency in FDA compliance.
Organized, efficient, process-oriented; high attention to detail
Effective interpersonal/communication skills
Works well under pressure in a dynamic timeline-driven environment
Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skill

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)