Principal regulatory affairs specialist - medtronic diabetes group (remote)
The diabetes operating unit focuses on improving the lives of those within the global diabetes communityAs a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need itWe’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easierOur portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
The medtronic diabetes group offers an integrated system combining our minimed insulin pump therapy with our continuous glucose monitoring systemsTogether, we will transform diabetes care by expanding access, integrating care, and improving outcomes; so people with diabetes can enjoy greater freedom and better health.
We value what makes you uniqueBe a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe
Whatever your specialty or ambitions, you can make a difference at medtronic – both in the lives of others and your career.
Careers that change lives
As principal regulatory affairs specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodiesWorking with global regulatory affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations.
This role focuses on products with software and/or interoperability with other devices or external networksIn this role, you will have primary ra responsibility for multiple class ii and class iii products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.
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
Team with business unit regulatory affairs specialists (ras) and international regulatory staffs to provide regulatory support for new productsWork with ras, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.
Prepare regulatory (eg, fda/notified body) submissions for new products and product changes, as required, to ensure timely approvals for market releaseReview significant product submissions with manager and negotiate submission issues with agency personnel.
Provide support to currently marketed products as necessaryThis includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
Interact directly with fda/notified body and indirectly with international regulatory agencies on most projects/products at reviewer levelAll significant issues will be reviewed with the manager.
Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
Apply software and security (i.e., cybersecurity) regulatory standards, guidance documents, and industry expectations to product strategies and submissionsGuides others in the organization who are working on similar products.
Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.
Provide regulatory input to product lifecycle planning.
Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
Provide feedback and on-going support to product development teams for regulatory issues and questions.
Ensure personal understanding of all quality policy/system items that are personally applicable.
Follow all work/quality procedures to ensure quality system compliance and high-quality work
Other duties as assigned.
Must have: minimum requirements
Bachelors degree required
Minimum of 7 years of medical device regulatory experience, or advanced degree with a minimum of 5 years medical device regulatory experience
Nice to have
Experience in pre-sub, ide, 510(k), de novo, pma, technical file/design dossier, including ide and software-containing devices.
Prior direct involvement with product development teams
Working knowledge of iec 60601-series standards
Software-related regulatory experience required (e.g., iec62304, fda software/cybersecurity guidance documents)
Prior experience with software-driven devices
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)
Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
Must be able to write clear, understandable technical documents, i.eRegulatory 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
About medtronic
Together, we can change healthcare worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt 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 teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp 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 jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer, and communicate with peers and co-workersContact 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)
A commitment to our employees lives at the core of our valuesWe recognize their contributionsThey share in the success they help to createWe 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: benefits.medtronic.com
This position is eligible for a short-term incentive planLearn more about annual salary and medtronic incentive plan (mip) on page 6 here.
