Principal Regulatory Affairs Specialist (remote) at Medtronic in Northridge, California

Job Description:

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.

We value what makes you unique. Be 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.

Medtronic is a $32b company with 90,000+ employees in more than 160 countries.

A Day in the Life

As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations.

This role focuses on products with hardware and/or interoperability with other devices or external networks. In this role, you will have primary RA responsibility for multiple Class II (IIa/IIb) 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.

Responsibilities may include the following and other duties may be assigned.

• Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under MDD and MDR Regulation. Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS) geographies.
• Prepare Technical Files /Design Dossier, Change Notifications, Submissions (e.g. Documentary Audits under MDD/ MDR)
• Advance knowledge regarding software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 )
  
  
  • Software Development & Validation for class B & class C
  • Risks control for above mentioned class B & class C software
  • Understand software requirements (functionalities, capabilities, input data, output data, system interfaces, alarms, security requirements, cybersecurity requirements, user interface requirements, database requirements, installation requirements, requirements related to methods of operation and maintenance, regulatory requirements, etc.)
  • Architecture and detailed design (for class B & class C)
  • Knowledgeable regarding Software verification, Validation, release, software maintenance .
  • Knowledgeable regarding Software configuration: identification of SOUP software, Configuration of the software system including identification of configuration items and their versions, etc.
• Creates, reviews and approves engineering change requests.
• Assist with defining the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.
• Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
• Prepare regulatory submissions for new products and product changes, as required, to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
• Reviews protocols and reports to support regulatory submissions.
• Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring agency approval.
• Interact directly with Notified Bodies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
• Maintain proficiency in global regulatory requirements; establish and maintain good relationships with agency personnel.
• Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides 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.
• Assist with 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 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
• Acts as liaison between the Company and the various regulatory agencies. Interfaces directly Notified Bodies
• Other duties as assigned.

Must Have: Minimum Requirements

• Bachelor's degree and a minimum of 7 years of regulatory experience within the medical device, biotech, or pharmaceutical industries
• Or advanced degree and a minimum of 5 years of regulatory experience within the medical device, biotech, or pharmaceutical industries

• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and European Medical Device Regulation 2017/745
• Ability to work effectively on project teams.
• Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
• Strong written, verbal, presentation, and organizational skills
• Strong analytical and problem-solving skills
• Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience with medical device software requirements and software regulations.
• Ability to identify risk areas and escalate issues as appropriate.
• Prior direct involvement with product development teams
• Working knowledge of ISO 13485 and ISO 14971 standards
• Good understanding of product development process and design control through knowledge of US, EU & international medical device regulations
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation and scientific presentations
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations.
• Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, and quality assurance internally and external with respect to submissions, registrations, obtaining approval/clearance, and post marketing compliance.
• Organized, efficient, process-oriented, high attention to detail.
• Effective interpersonal/communication skills
• Supporting products from initial concept through end-of-life phases
• Ability to effectively manage multiple projects and priorities.
• Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills.
• Works well under pressure in dynamic timeline-driven team and individual environments.

• Regulatory Affairs Certification (RAC)

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)

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 .