Medtronic Principal Regulatory Affairs Specialist - Software (Remote) in North Haven, Connecticut
Principal Regulatory Affairs Specialist - Software (Remote)
North Haven, Connecticut, United States
Jul 21, 2021
Careers that Change Lives
In Surgical Innovations, we advance minimally invasive surgery to improve outcomes for patients and providers around the globe. From concept to commercialization, we bring meaningful innovation to our robust and growing portfolio of surgical devices and technologies. Through wise investments, thoughtful planning, and world-class partnerships, we help patients get the care they need from diagnosis to treatment when they need it.
The Principal 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 principal specialist works directly with the NPD team from the concept phase through commercialization. The principal 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 for software-driven surgical stapling devices and/or accessories. https://www.medtronic.com/covidien/en-us/products/surgical-stapling.html 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. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
To learn more about Inclusion Diversity at Medtronic Click Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)
A Day in the Life
Provide strategic input and technical guidance on regulatory requirements for new technologies, new product development and product modifications, considering both domestic and international regulations
Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Technical writing for preparation of Pre-Sub and 510(k) submissions and technical documents/Design Dossier to support CE mark and other international submissions
Demonstrated history of successful regulatory submissions in the US and EU
Effect technical communication skills in collaboration with FDA, Notified Body and/or other governing agencies Including participation in negotiations and interactions during the development and review process
Working knowledge of IEC 60601-series standards
Previous experience with software-driven devices
Strong interpersonal, analytical, writing, and organizational skills, including the ability to navigate the grey
Provide product information to the international regulatory affairs team to support global registration and support international product registrations as needed
Develop global regulatory strategies and requirements and communicate that information to the core team
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
Review promotional and advertising material
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Participate in internal and external audits as needed
Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
Perform other duties as requested
Must Have (Minimum Requirements):
- Bachelors degree required and a minimum of 7 years of medical device regulatory experience, or advanced degree with a minimumof 5 years of medical device regulatoryexperience
Nice to Have (Preferred Qualifications):
Advanced degree in a scientific discipline
Experience with regulatory support of clinical trials for medical devices
Experience in IDE, De Novo, or PMA submissions
Ability to analyze and resolve non-routine regulatory issues using independent judgment
Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
RAC credential preferred
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. Lets 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)
Ability to travel up to 10%
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.