SENIOR REGULATORY AFFAIRS SPECIALIST - Digital Technologies

The Senior Regulatory Affairs Specialist will play a key role in launching new products and sustaining the current product portfolio. As a new product development (NPD) core team member, the Senior Specialist works directly with the NPD 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 regulatory submissions worldwide. Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, 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.

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

Business Unit

In the Surgical Digital Technologies (DT) 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 laparoscopic AI/ML analytics-based 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.

Careers That Change Lives

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.

A Day In The Life

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Additional tasks as assigned

• Bachelor’s degree with 4 years of experience in regulatory affairs

OR

• An advanced degree with 2 years of experience in regulatory affairs

• Experience in Pre-Sub, IDE, 510(k), De Novo, or PMA; Technical File/Design Dossier, and software-containing devices.
• Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
• Prior direct involvement with software and/or AI product development teams
• Working knowledge of IEC 62304 standard
• Working knowledge of IEC 60601-series standard
• Prior experience with software-driven devices
• Familiarity with regulatory requirements in major international markets
• Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs
• 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
• Ability to effectively manage multiple projects and priorities
• Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

Compensation

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here. 

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.