Regulatory Affairs Specialist

2 weeks ago

Los Angeles CA, United States Medtronic Inc. Full time

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 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.
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.
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.
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.
Documentary Audits under MDD/ MDR)
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. Reviews protocols and reports to support regulatory submissions.
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. Maintain proficiency in global regulatory requirements; Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions. 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. 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.
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.
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.
Ability to effectively manage multiple projects and priorities.
Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills.
Regulatory Affairs Certification (RAC) or Master's degree
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. Help us shape the future.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: 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. (They share in the success they help to create. This position is eligible for a short-term incentive plan.

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