Regulatory Affairs Specialist
$74.4k - $111.6kMedtronic plc
- # Especialista asuntos regulatoriosSolicitarremote type: Presenciallocations: Minneapolis, Minnesota, United States of Americatime type: Tiempo completoposted on: Publicado hoytime left to apply: Fecha final: 22 de agosto de 2026 (Quedan 21 días para realizar la solicitud)job requisition id: R73390We anticipate the application window for this opening will close on - 22 Aug 2026En Medtronic, puedes empezar una carrera para toda la vida que se centre en la investigación y en la innovación y que defienda la equidad y el acceso a la atención sanitaria para todos. Tu liderazgo dejará huella, eliminando obstáculos para impulsar la innovación en un mundo más conectado y humanitario.**Un día normal** Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life.Check us out on LinkedIn: Medtronic Brain Modulation and Pain InterventionsAt Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In collaboration with leading clinicians, researchers, and scientists worldwide,**Role Overview**The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market. This role involves:* Providing expert advice on regulatory requirements* Preparing submissions* Supporting approval activities* Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations**Responsibilities Include, But Are Not Limited To:*** Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.* Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.* Prepare FDA, European, and Canadian submissions for product changes to ensure timely market release approvals.* Review regulatory issues with the manager as necessary and support the resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies.* Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.* Provide regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation.* Provide feedback and ongoing support to product development teams for regulatory issues and questions.* Interact with FDA and international regulatory agencies on assigned projects/products, with significant issues reviewed with the manager.**To Be Successful in This Role*** **Medical Device Experience:** Experience in the medical device industry, including exposure to Class II and/or Class III medical devices (510(k) and some PMA).* **Regulatory Submission Expertise:** Experience preparing and supporting regulatory filings to the FDA (including 510(k) and some PMA), EU MDR, and other global regulatory agencies.* **Knowledge of Regulatory Requirements:** Understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.**Must Have: Minimum Requirements*** Bachelor’s degree in a scientific discipline or equivalent* Minimum **2 years of regulatory affairs experience****Nice To Have*** Experience in regulatory affairs, including conducting change assessments for Class II (510(k) devices).* Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences).* Exposure to device submissions and interactions with regulatory agencies.Para los títulos de bachillerato obtenidos fuera de los Estados Unidos, se requiere un título que satisfaga los requisitos de 8 C.F.R. § 214.2 (h) (4) (iii) (A).**Requisitos físicos del puesto**Las declaraciones anteriores pretenden describir la naturaleza general y el nivel de trabajo que realizan los empleados asignados a este puesto, pero no constituyen una lista exhaustiva de todas las responsabilidades y habilidades requeridas para dicho puesto.Las exigencias físicas descritas dentro de la sección Responsabilidades de esta descripción de puesto son representativas de las que se deben cumplir por parte de un empleado para desempeñar exitosamente las funciones esenciales de este puesto. Se pueden hacer las adaptaciones razonables para permitirles a las personas que tengan discapacidades desempeñar las funciones esenciales. Para las funciones de oficina: mientras desempeña las responsabilidades de este puesto, el empleado debe desplazarse con regularidad de forma independiente. El empleado también debe interactuar con una computadora y comunicarse con sus colegas y compañeros de trabajo. Póngase en contacto con su gerente o con el departamento de RR. HH. local para conocer las condiciones de trabajo y los requisitos físicos que pueden ser específicos de cada función.**Autorización de Trabajo y Patrocinio** En Medtronic, tenemos el compromiso de fomentar un entorno donde los empleados puedan prosperar y tener un impacto significativo. En consonancia con nuestro enfoque de planificación de la fuerza laboral en toda la empresa, el patrocinio de autorización de trabajo de los EE. UU. (H-1B, TN, J, etc.) se ofrece exclusivamente para roles de nivel principal y superior, donde la experiencia especializada se alinea con las necesidades comerciales a largo plazo. Los roles por debajo del nivel principal requieren que los candidatos posean una autorización de trabajo sin restricciones de los EE. UU. al momento de la contratación y durante la duración del empleo. Únase a nuestra misión de aliviar el dolor, restaurar la salud y prolongar la vida, donde se valoran sus antecedentes y perspectivas únicos.**Recruitment Fraud Alert**We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io.**Beneficios y compensación****Medtronic ofrece un salario competitivo y un paquete de beneficios flexible** El compromiso con las vidas de nuestros empleados es el centro de nuestros valores. Reconocemos sus aportes. Comparten el éxito que contribuyen a crear. Ofrecemos una amplia gama de beneficios, recursos y planes de compensación competitivos diseñados para apoyarlo en cada etapa de su carrera profesional y de la vida.Salary ranges for U.S (excl. PR) locations (USD):$74,400.00 - $111,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).## ## The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information applies solely to candidates hired within the United States (local-market compensation and benefits will apply to others).The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below:Planes de compensación y beneficios de Medtronic**Acerca de Medtronic** Somos líderes en tecnología de atención médica a nivel mundial y abordamos con decisión los problemas de salud más complejos a los que se enfrenta la humanidad mediante la búsqueda y el hallazgo de soluciones. Nuestra misión (aliviar el dolor, devolver la salud y alargar la vida) une a un equipo global de más de 95 000 personas apasionadas. Somos ingenieros de corazón: ponemos en práctica ideas ambiciosas para generar soluciones reales para personas reales. Desde el laboratorio hasta la fábrica, pasando por la sala de conferencias, cada uno de nosotros experimenta, crea, construye, mejora y aporta soluciones. Contamos con el talento, las diferentes perspectivas y la ambición necesarios para desarrollar lo extraordinario. Obtenga más información sobre nuestra empresa, misión y compromiso con la diversidad aquí Es la política de Medtronic proporcionar igualdad de oportunidades de empleo (EEO, por sus siglas en inglés) para todas las personas, independientemente de su edad, color, origen nacional, estado de ciudadanía, discapacidad física o mental, raza, religión, credo, género, sexo, orientación sexual, identidad y/o expresión de género, información genética, estado civil, estado en relación a la asistencia pública, estado como veterano o cualquier otra característica protegida por las leyes federales, estatales o locales. Además, Medtronic proporcionará asistencia especial razonable para los individuos calificados con alguna discapacidad.
- J-18808-Ljbffr Medtronic plc
Vacancy posted 15 hours ago
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