Staff Regulatory Affairs Specialist

Staff Regulatory Affairs Specialist

13 ene
|
Stryker India
|
Tampico

13 ene

Stryker India

Tampico

Job Description Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Regulatory Specialist to join our Neurovascular Division to be based remotely anywhere within the United States. Strykers Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions.





The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSESYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to Make Stroke History. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference https//www.youtube.com/watch?v=JANFZrpt1Hg. Who we want Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams. Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. What you will do As the Staff Regulatory Affairs Specialist, you will be responsible for the coordination and preparation of submissions for regulatory body consultations, clinical trial applications as well as commercial launch applications in the following geographic regions United States, Europe, and Canada. Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions. Assist in the development of regulatory strategy and updates strategy based upon regulatory changes. Evaluate proposed products for regulatory classification and jurisdiction. Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization. Negotiate with regulatory authorities throughout the product lifecycle. Provide regulatory input and technical guidance on global regulatory requirements to product development teams. Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations. Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations. Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategizes (if appropriate) for changes that do not require submissions. Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims. Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines. Monitor the progress of the regulatory authority review process through appropriate communications with the agency. Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools. Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees. What you need A Bachelors Degree (B.S or B.A) in Engineering, Science or equivalent focus is required. A minimum of 5 years of experience in an FDA regulated industry required; preferably with medical devices. A minimum of 3 years of Medical Device Regulatory Affairs experience required. RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. General understanding of product development process and design control. General understanding of regulations applicable to the conduct of clinical trials. Thorough understanding of FDA and international medical device regulations. Previous experience with Class II or III medical devices required. Previous experience drafting or working on regulatory submissions required. Experience interacting with regulatory agencies preferred. Ability to comply with constantly changing regulatory procedures and prioritize work effectively. Ability to analyze and resolve non-routine regulatory issues using independent judgment. Excellent analytical and writing skills. Excellent interpersonal, written and oral communication skills. Effective organizational skills. Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

Agente de ventas - Tampico

Agente de ventas - Tampico

- Este puesto requiere tener una excelente actitud de servicio y contar con el certificado de preparatoria como comprobante mínimo de escolaridad. Estamos buscando el perfil de alguien que sea responsable de un mostrador de servicios de mensajer [...]
Tampico
18 ene
    Tampico
    18 ene

Promotor (Perfumería de Lujo) $5000 + Variable - Tienda Departamental o Plaza

Promotor (Perfumería de Lujo) $5000 + Variable - Tienda Departamental o Plaza

- Importante compañía multinacional dentro del mercado laboral y de marca de belleza, Solicita Promotor Zona Tampico, CD Victoria Labores a realizar: - Ventas presenciales - Apoyo al área de mostrador. Horarios: - Horario lunes [...]
Tampico
18 ene
    Tampico
    18 ene

Promotor de Créditos Lunes a viernes!!! Tampico

Promotor de Créditos Lunes a viernes!!! Tampico

Empresa 100% Mexicana con presencia a nivel nacional con más de 10 años de experiencia en el mercado, solicita personal para integrarlo de manera inmediata a su equipo de trabajo. Actividades: Prospección de clientes en diferentes dependencias d [...]
Tampico
18 ene
    Tampico
    18 ene

EMPLEADO DE MOSTRADOR

EMPLEADO DE MOSTRADOR

Salario neto mensual: $4,280.00 Ubicación: Tamaulipas, Tampico - Tipo de contrato: Contrato por tiempo indeterminado Vigencia de la oferta: 14 de febrero de 2021 Días laborales: L Ma Mi J V S Horario de trabajo: 8:00 a 19:00 h [...]
Tampico
17 ene
    Tampico
    17 ene