Talent.com
Esta oferta de trabajo no está disponible en tu país.
Regulatory Affairs Specialist- EBD

Regulatory Affairs Specialist- EBD

DivurgentBarcelona, Cataluña, España
Hace más de 30 días
Descripción del trabajo

Job Details : Regulatory Affairs Specialist- EBD

Full details of the job.

Vacancy Name

Vacancy Name Regulatory Affairs Specialist- EBD

Vacancy No

Vacancy No VN309

Employment Type

Employment Type Full-Time

Location

About the Job

Sinclair is looking for a Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBD). In this role, you will ensure compliance with international regulatory authorities and support market entry for EBDs worldwide. You will collaborate with cross-functional teams to maintain and submit regulatory approvals, driving the successful launch of products in global markets. This is an exciting opportunity to contribute to the efficiency and effectiveness of regulatory processes while ensuring alignment with global standards and business objectives.

About Sinclair

Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.

This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

Our Vision

Providing aesthetic excellence globally.

Our Mission

Driving the advancement of product quality and customer satisfaction, investing in innovation and people.

Our Values

  • Act with Integrity
  • Stay ahead of the game
  • One team, one goal

Description

Description Essential :

  • Bachelor's degree in Life Sciences or related field, or equivalent work experience in regulatory affairs with a focus on medical device product registrations.
  • 3+ years of experience in Regulatory Affairs within the Medical Devices industry.
  • Proficiency in computer skills, including but not limited to Windows and MS Office.
  • Full proficiency in English is required.
  • Role Competencies :

  • Expertise in regulatory pathways and documentation requirements for device registrations.
  • Ability to manage complex projects and deliverables within specified timelines.
  • Self-motivated and able to work autonomously and proactively.
  • Strong attention to detail with a methodical approach to documentation and data management.
  • Collaborative team player with the ability to work in a multidisciplinary environment.
  • Demonstrates personal responsibility and confidence, with excellent written and verbal communication skills.
  • Assertive, decisive, and able to positively influence others across the company.
  • Strong time and priority management; excellent planning and organizational skills.
  • Promotes a culture of accuracy and quality throughout the business.
  • Flexible and adaptable, with a team-oriented mindset.
  • General Competencies :

  • Strong analytical and deductive reasoning skills.
  • Attention to detail.
  • Excellent communication skills.
  • Goal-oriented with a rigorous yet flexible approach.
  • Adaptable and open-minded.
  • High integrity and adherence to professional ethics.
  • Ability to cooperate effectively across functions and teams.
  • If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

    Please note if we receive a high volume of applications, we may close the role before the closing date noted.

    By making this application you give consent for personal information to be used in automated decision making processes relating to key job requirements which are stated in this ad.

    If you have any questions, please email .

    Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.

    Key Responsibilities

    Key Responsibilities Roles and Responsibilities :

  • Prepare, submit, and manage regulatory applications for Energy-Based Device (EBD) product registrations, amendments, renewals, and post-approval changes in assigned countries based on company priorities.
  • Coordinate with cross-functional departments to gather and compile necessary documentation for product registrations, ensuring compliance with country-specific regulatory requirements.
  • Monitor and interpret international regulatory requirements for EBD product registrations, providing strategic advice and assessing operational impacts.
  • Advise on jurisdiction-specific regulatory requirements, ensuring that these are communicated and incorporated into the design inputs and development processes of new and existing products.
  • Collaborate in the development and revision of Standard Operating Procedures (SOPs) related to regulatory processes, contributing to the continuous improvement of the company's regulatory compliance framework.
  • Maintain up-to-date records of registration statuses, submissions, and communications with regulatory authorities and involved stakeholders, including distributors and importers.
  • Perform administrative tasks such as processing document legalization at embassies and consulates to support the registration of products in different countries.
  • Perform other regulatory affairs duties as assigned.
  • Benefits We offer :

  • Competitive fixed salary aligned with the market + variable.
  • Medical + Dental Insurance.
  • Hybrid work model.
  • Flexible schedule + short Friday.
  • Fruit at the office.
  • Enjoyable, dynamic and international environment.
  • We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

    J-18808-Ljbffr

    Crear una alerta de empleo para esta búsqueda

    Regulatory Specialist • Barcelona, Cataluña, España

    Ofertas relacionadas
    • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Tailored PerfumesGavà, Catalonia, España
    Tailored Perfumes se presenta como un referente en la industria de la perfumería y belleza.Con sede en España, contamos con una red de distribución global, vendiendo en más de 100 países y alcanzan...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Advantage ConsultoresBarcelona, España
    For our client, a leading B2 B medical aesthetics group specializing in hyaluronic acid-based injectables and other solutions, we are seeking a Regulatory Affairs Specialist / Senior Regulatory Tec...Mostrar másÚltima actualización: hace 25 días
    • Oferta promocionada
    Regulatory Affairs

    Regulatory Affairs

    Robert Walters Spainbarcelona, España
    Nuestro cliente, empresa familiar especializada en la fabricación y distribución de ingredientes y principios activos para la industria del personal care, está en búsqueda de un perfil de regulator...Mostrar másÚltima actualización: hace 16 días
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    PuigBarcelona, B, ES
    We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to join our team.This role will primarily focus on Raw Material assessment, alongside data management and process st...Mostrar másÚltima actualización: hace 16 días
    • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Grupo ProfármacoBarcelona, España
    Somos un grupo internacional innovador, con amplia experiencia en lacomercialización de productos farmacéuticosen el ámbito geográfico de Centroamérica y el Caribe. Objetivo principal del puesto : Ges...Mostrar másÚltima actualización: hace 26 días
    • Oferta promocionada
    Regulatory Affairs Technician

    Regulatory Affairs Technician

    AB-Biotics, S.A.barcelona, España
    Technological knowledge (PhD or Master’s degree in molecular biology, biotechnology, pharmacy, biomedicine, or similar).Product technical specifications knowledge. Languages knowledge (English, Span...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Dermofarmrubí, España
    Talent Manager en Dermofarm | Master Dirección de RRHH.En Dermofarm, buscamos personas que compartan nuestros valores de honestidad científica, rigor farmacéutico y sostenibilidad ambiental para in...Mostrar másÚltima actualización: hace más de 30 días
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    UnilabsBarcelona, Catalonia, ES
    Quick Apply
    Unilabs' compliance with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017 / 746 (IVDR) and equivalent frameworks across our laboratories in Europe. You’ll work cross-functionally to embed ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    • Nueva oferta
    Regulatory Affairs Specialist Cmc

    Regulatory Affairs Specialist Cmc

    ManpowergroupBarcelona, España
    Desde ManpowerGroup Talent Solutions estamos buscando un / a Regulatory Affairs Specialist CMC para el Área de R&D de una multinacional farmacéutica referente en medicamentos genéricos de valor añadi...Mostrar másÚltima actualización: hace 16 horas
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    SolutiaghsBarcelona, ES
    Solutia Life Sciences (recruitment division of Solutia) specializes in technical and middle management profiles in the pharmaceutical, biotech, and medical device sectors.Coordinating regulatory ac...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Biopharma Regulatory Affairs Specialist

    Biopharma Regulatory Affairs Specialist

    Grifols, S.ASant Cugat del Vallès, Cataluña, España
    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Logistics Regulatory Affairs

    Logistics Regulatory Affairs

    MSF Internationalbarcelona, España
    Duration : 6 months, with possibility of extension.Deadline to apply : 26th of May 2025.Compensation and benefits : MSF practice is to offer the C&B package current in the MSF entity establishing t...Mostrar másÚltima actualización: hace 24 días
    • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    HaysBarcelona, España
    Buscamos un / a Regulatory Affairs Specialist con experiencia consolidada en el sector farmacéutico y / o parafarmacéutico para uno de nuestros principales clientes. Compañía farmacéutica ubicada en los...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    GL Scientificbarcelona, España
    Are you an experienced Regulatory Affairs professional? Join our team as a Regulatory Affairs Manager and play a vital role within G&L Scientific team. This role focuses on cross-functional activiti...Mostrar másÚltima actualización: hace 2 días
    • Oferta promocionada
    Regulatory Affairs Technician

    Regulatory Affairs Technician

    Tradebe Health & Nutrition (Clinical Nutrition S.A.U)Barcelona, Cataluña, España
    Crear una alerta de empleo para esta búsqueda.Te apasiona el Retail y el trato con el cliente? ¿Te gustaría formar parte de los sueños de las familias y crear momentos inolvidables con nuestros jug...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Officer

    Regulatory Affairs Officer

    ASPHALIONbarcelona, España
    Asphalion is growing and we are looking for a.Someone who loves to take new challenges, to work in an international environment and who wants to grow with us!. Submissions of MAA, variations, renewa...Mostrar másÚltima actualización: hace 24 días
    • Oferta promocionada
    • Nueva oferta
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    WhatJobsGavà, Kingdom Of Spain, España
    Quiénes somos?Tailored Perfumes se presenta como un referente en la industria de la perfumería y belleza.Con sede en España, contamos con una red de distribución global, vendiendo en más de 100 paí...Mostrar másÚltima actualización: hace 10 horas
    • Oferta promocionada
    Regulatory Affairs Support Specialist

    Regulatory Affairs Support Specialist

    GaldermaBarcelona, Provincia de Barcelona, España
    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.We deliver an innovative, science-based portfolio of premium flagship brands and services that ...Mostrar másÚltima actualización: hace 5 días
    • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    buscojobs Españabarcelona, España
    Regulatory Affairs Specialist (Full-time, Permanent).Prinova is a leading global supplier of ingredients and premix manufacturing solutions for the food, beverage, and nutrition industries.We hold ...Mostrar másÚltima actualización: hace 16 días
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    GrifolsSant Cugat del Valles, ES
    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1...Mostrar másÚltima actualización: hace 16 días