Regulatory Affairs Specialist

Encontrado en: Jooble MX O C2 - hace 2 semanas

Ciudad de México Edwards Lifesciences Gruppe A tiempo completo
We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience.

Regulatory Affairs Specialist (temporary position) page is loaded Regulatory Affairs Specialist (temporary position) Apply locations Mexico-Mexico City time type Full time posted on Posted 4 Days Ago job requisition id Req-32569

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

How you´ll make an impact

  • Completes and maintains regulatory approvals and clearances of assigned products.

  • Create regulatory submissions/playbook, exercising judgment to protect proprietary information) for finalization and submission

  • Track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, COE, Canada)

  • Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activites in Edwards systems to ensure compliant product distribution.

  • Identify trends, assess impact, analyze alternatives and recommend action plans

  • Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, and resolving conflicts between those requirements and development issues, and/or reporting to management.

  • Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulations

  • Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies

  • Review and approve materials (e.g., collateral) from cross-functional teams

  • Incidental: Other duties as assigned by Management

What you will need

  • Bachelor's Degree in related field

  • 3 years of previous related experience required

  • Education in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred

  • Other: Coursework, seminars, and/or other formal government and/or trade association training Preferred

  • English level preferred

What else will help you
  • Good medical writing skills
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
  • Good problem-solving, decision-making, organizational, analytical and critical thinking skills
  • Good written and verbal communication skills and interpersonal relationship skills
  • Ability to read, write and speak English required
  • Solid knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)
  • Solid knowledge and understanding of global regulatory requirements for new products or product changes.
  • Solid knowledge of new product development systems
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
  • Ability to build productive internal/external working relationships
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
About Us

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

#J-18808-Ljbffr

  • Regulatory Affairs Specialist

    Encontrado en: Jooble MX O C2 - hace 2 semanas

    México Groupe ProductLife A tiempo completo

    In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. Responsibilities Provide guidance and support about Mexican and Central America legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...

  • Regulatory Affairs Qro

    hace 9 horas

    México Tata Consultancy Services A tiempo completo

    We are a multinational company in the technology consulting and services field, with presence in 46 countries and more than 600,000 employees. Our company is looking for an **Regulatory Affairs**, Functions to join the team: Required Experience: - **COMPLETE YOUR APPLICATION THAT WILL BE SENT BY MESSEGE ON INDEED**: - Regulatory advice to drug development...

  • Regulatory Affairs Specialist

    hace 7 días

    Ciudad Juarez, México BEPC Inc A tiempo completo

    Develop and maintain regulatory strategies for the development, registration, and commercialization of medical devices - Communicate with regulatory authorities to obtain timely approvals for medical devices - Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations - Monitor regulatory changes and provide...

  • Head of Regulatory Affairs and QA

    hace 6 días

    Ciudad de México IPSEN A tiempo completo

    **Title**: Head of Regulatory Affairs and QA (Mexico & Export markets) **Company**: Ipsen Mexico S de RL de CV Head of Regulatory Affairs and QA (Mexico & Export markets)

  • Regulatory Affairs Specialist

    Encontrado en: Jooble MX O C2 - hace 2 semanas

    Ciudad de México Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...

  • Regulatory Affairs Analyst

    Encontrado en: Jooble MX O C2 - hace 2 semanas

    Ciudad de México Viatris A tiempo completo

    Regulatory Affairs Analyst (Fixed Term) page is loaded Regulatory Affairs Analyst (Fixed Term) Postuler locations Mexico City, Mexico time type Temps plein posted on Offre publiée hier job requisition id R5646189 Viatris Healthcare México S. de R.L. de C.V Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait...

  • Manager, Regulatory Affairs

    hace 6 días

    Ciudad de México Biogen A tiempo completo

    **Job Description**: **About This Role** Reporting to the Sr. Manager, Regulatory affairs, the Manager supports all regulatory strategies creating tactics for new products at local and global levels. **What you will do**: - Responsible for precise and aligned communication with local teams and global Regulatory team. - Coordinate all post-registration...

  • Senior Manager, Regulatory Affairs

    Encontrado en: Jooble MX O C2 - hace 3 semanas

    México Worldwide Clinical Trials, LLC A tiempo completo

    Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...

  • Regulatory Affairs Manager

    Encontrado en: Jooble MX O C2 - hace 3 semanas

    Ciudad de México Unilever Brazil A tiempo completo

    Full/Part Time: Full Time Location: Mexico, Brazil Business Context Established in 2018, Unilever’s US-centric Health & Wellbeing business is a collective of fast-growing, science-backed companies powering a lifestyle of wellbeing designed for a lifetime of possibilities. Comprised of Liquid I.V., Nutrafol, OLLY, Onnit, SmartyPants, Welly and Equilibra...

  • Regulatory Affairs Manager

    Encontrado en: Jooble MX O C2 - hace 3 semanas

    México Unilever A tiempo completo

    Regulatory Affairs Manager page is loaded Regulatory Affairs Manager Solicitar locations Col. Bosques de las Lomas, Mexico time type Tiempo Completo posted on Publicado hace 7 días job requisition id R-86602 Full/Part Time: Full Time Location: Mexico, Brazil Business Context Established in 2018, Unilever’s US-centric Health & Wellbeing business is...

  • Senior Regulatory Affairs Manager

    hace 7 días

    Edo. de México Artixio Consulting Pvt Ltd A tiempo completo

    Artixio is a global regulatory and quality services company with offices in USA, Germany, UAE, India and affiliates in about 70 countries. As next leap of our growth, we plan to expand our presence in Mexico. We are inviting Regulatory Affairs Leaders to join our regional team. We are seeking entrepreneurial professionals who wish to be part of the...

  • Regulatory Specialist Latam

    Encontrado en: Jooble MX O C2 - hace 3 semanas

    Ciudad de México Red Bull Gruppe A tiempo completo

    The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...

  • Regulatory Affairs Specialist III

    Encontrado en: beBee S MX - hace 1 semana

    Ciudad de México Thermo Fisher Scientific A tiempo completo

    Location Mexico City, Mexico Job Id R-01227994 Prepares, reviews and coordinates, under guidance and local EC submissions in. Supports preparation, under guidance, of local...

  • Regulatory Affairs Officer

    Encontrado en: Jooble MX O C2 - hace 3 semanas

    Estado de Chiapas, México Groupe ProductLife A tiempo completo

    In the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market. Responsibilities Management of post approval activities (Life Cycle Management) for the Canadian market Initiate change...

  • Regulatory Science Analyst

    hace 2 días

    Ciudad de México Pfizer A tiempo completo

    Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

  • Regulatory Specialist Ii

    hace 4 días

    México Sensient Technologies A tiempo completo

    As a valued member of our Sensient global Regulatory team, in this role as a Regulatory Specialist you assure the compliance of our products with appropriate regulations, provide various data, information and conformity declaration, and you serve as a regulatory resource to internal and external customers. You maintain technical databases related to raw...

  • Regulatory Affairs Specialist

    hace 4 días

    Ciudad de México Johnson & Johnson A tiempo completo

    En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad. La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y...

  • Regulatory Affairs Manager Latam

    Encontrado en: beBee S MX - hace 3 semanas

    Huixquilucan de Degollado, México Philips A tiempo completo

    Job TitleRegulatory Affairs Manager Latam (Medical Equipment)Job DescriptionJob title:Regulatory Affairs Manager Latam (Medical Equipment)Your role:To formulate and implement the HPM Businesses and / or Markets long-range regulatory strategies for LATAM (Latin America).Main point of contact between BU, Market and Local Business Team for product registration...

  • Regulatory Affairs Manager Latam

    Encontrado en: beBee S MX - hace 3 semanas

    Huixquilucan de Degollado, México Philips A tiempo completo

    Job TitleRegulatory Affairs Manager Latam (Medical Equipment)Job DescriptionJob title:Regulatory Affairs Manager Latam (Medical Equipment)Your role:To formulate and implement the HPM Businesses and / or Markets long-range regulatory strategies for LATAM (Latin America).Main point of contact between BU, Market and Local Business Team for product registration...

  • Regulatory Affairs Supervisor Latam

    Encontrado en: beBee S MX - hace 2 semanas

    Huixquilucan de Degollado, México Philips A tiempo completo

    Job TitleRegulatory Affairs Supervisor Latam (Medical Equipment)Job DescriptionJob title:Regulatory Affairs Supervisor Latam (Medical Equipment)Your role:To formulate and implement the HPM Businesses and / or Markets long-range regulatory strategies for LATAM (Latin America).Main point of contact between BU, Market and Local Business Team for product...