Senior Regulatory Affairs Engineer
hace 3 meses
Job Details: Senior Regulatory Affairs Engineer (Pre-Market)Full details of the job.Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market)Vacancy No: VN179Employment Type: Full-TimeLocation: Esplugues del Llobregat (Barcelona)The RoleSinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in Esplugues del Llobregat (Barcelona). Working within the Corporate Regulatory Affairs Team, the Pre-Market Regulatory Affairs Engineer ensures regulatory requirements are met for new product development and design changes to established legacy devices.Reporting to the Team Leader Registration and Regulatory Affairs Engineer, the position holder assures the design and development processes contain the correct regulatory requirements and supporting evidence. Working closely with Research and Development and other business departments, the position holder will also ensure the type of testing certification such as electrical compatibility and compliance to product-specific standards and directives. This assures the integrity of the design history file and technical documentation as a precursor to country-specific registration(s).This position provides and contributes to the Regulatory deliverables from internal Research and Development projects, contributing to providing Regulatory solutions to business requirements and changes to the regulatory landscape. This position provides operational Regulatory input and guidance to cross-functional teams, ensuring compliance to the UK, European, USA, and International country-specific legislations.This position will prepare dossiers and technical documentation for product submissions worldwide, and will be responsible for the management of the submission with the regulatory agency.Your Skills & Experience – Do You Have What it Takes?Essential:Minimum 5 years experience in Regulatory Affairs (Pre-Market) within a Medical Device and with active medical devices (energy devices).Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304).Experience with the Medical Device Regulation.Knowledge of other regulatory legislation and guidelines, e.g., UE, EEUU and Canada regulations.Excellent attention to detail when reviewing and preparing documentation.Organised, target-orientated, flexible, good time management skills.Strong written and oral communication skills.Fluency in written and spoken English.Ideally, if you also have experience with cybersecurity or AI.A bit about you – do you fit this description?Personal responsibility.Able to work autonomously and proactively.Communication, impact and influence.Analytical and critical thinking capacity.Time management, organization and planning.Work accurately with attention to detail and promote quality culture through the business.Orientation towards achievement.Adaptability and openness to change.Ability to learn.Integrity and professional ethics.Cross-disciplinary cooperation.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 ****** 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 ResponsibilitiesTo provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in UE, EEUU and Canada territories.Preparation of technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy.Establish and maintain regulatory information systems, technical documentation files and routine reports.Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.Ensure regulatory compliance to global requirements and company policies.Support new product development activities.Review documents and product changes for regulatory submission impact.To provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities.Review and approve product artworks and relevant marketing materials according to Sinclair strategies and any applicable regulatory requirements or standard.To identify, deliver and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs.Liaise with and assist vigilance team and risk management team with respect to requirements of product dossiers and relevant post marketing activities as and where necessary.Assist and support inspections and audits.Liaise with, assist, and support in the creation of QMS process for regulatory aspects.Responsible for the local implementation and training of regulatory process.Responsible for leading and monitoring the assigned registration processes in the countries of commercialization of the Company's medical devices.Coordination and preparation of the documentation associated to the registers of medical devices to be delivered to the national or international Health Authorities.Administrative tasks and procedures in the different embassies and consulates for the legalization of the different documents necessary for the registration of the products in the different countries.Coordinate the signature of Quality and Release certificates of cosmetics and medical devices.Deputise for Manager as required.BenefitsWe 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
-
Senior Regulatory Affairs Engineer
hace 2 meses
Barcelona, España Ablecloset A tiempo completo.Job Details: Senior Regulatory Affairs Engineer (Pre-Market) Full details of the job. Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market) Vacancy No: VN179 Employment Type: Full-Time Location: Esplugues del Llobregat (Barcelona) The Role Sinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in Esplugues...
-
Senior Regulatory Affairs Engineer
hace 3 meses
Barcelona, España Ablecloset A tiempo completo.Job Details: Senior Regulatory Affairs Engineer (Pre-Market)Full details of the job.Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market)Vacancy No: VN179Employment Type: Full-TimeLocation: Esplugues del Llobregat (Barcelona)The RoleSinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in Esplugues del...
-
Senior Regulatory Affairs Engineer
hace 3 meses
Barcelona, España Sinclair EBD A tiempo completoJob Details: Senior Regulatory Affairs Engineer (Pre-Market)Full details of the job.Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market)Vacancy No: VN179Employment Type: Full-TimeLocation: Esplugues del Llobregat (Barcelona)The Role Sinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in Esplugues del...
-
Senior Regulatory Affairs Engineer
hace 3 meses
Barcelona, España Sinclair EBD A tiempo completoJob Details: Senior Regulatory Affairs Engineer (Pre-Market) Full details of the job.Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market) Vacancy No: VN179 Employment Type: Full-Time Location: Esplugues del Llobregat (Barcelona) The Role Sinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in Esplugues...
-
Senior Regulatory Affairs Engineer
hace 4 meses
Barcelona, España Sinclair EBD A tiempo completoJob Details: Senior Regulatory Affairs Engineer (Pre-Market) Full details of the job.Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market)Vacancy No: VN179Employment Type: Full-TimeLocation: Esplugues del Llobregat (Barcelona)The RoleSinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in Esplugues del...
-
Senior Regulatory Affairs
hace 6 meses
Barcelona, España Antal International A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en Barcelona. **Requisitos**: - Formación Universitaria en Ciencias de la Salud - Más de 4 años con posiciones de Regulatory...
-
Senior Regulatory Affairs
hace 6 meses
Barcelona, España Antal International A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en Barcelona.**Requisitos**:- Formación Universitaria en Ciencias de la Salud- Más de 4 años con posiciones de Regulatory...
-
Senior Regulatory Affairs Engineer
hace 2 meses
Barcelona, España AbleCloset A tiempo completoJob Details: Senior Regulatory Affairs Engineer (Pre-Market) Full details of the job. Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market) Vacancy No: VN179 Employment Type: Full-Time Location: Esplugues del Llobregat (Barcelona) The Role Sinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in...
-
Senior Regulatory Affairs Director
hace 4 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completo.At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional...
-
Regulatory Affairs Senior
hace 6 meses
Barcelona, España Page Personnel España A tiempo completoTo be up to date on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development - Submission and follow-up of variations - Preparations of documents to new marketing authorisations (EU and non-EU countries) - Research and Development project managing...
-
Senior Regulatory Affairs Director
hace 2 semanas
Barcelona, España buscojobs España A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
-
Senior Regulatory Affairs Director
hace 2 semanas
Barcelona, España buscojobs España A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
-
Senior Regulatory Affairs Director
hace 2 semanas
Barcelona, España buscojobs España A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
-
Senior Regulatory Affairs Director
hace 4 semanas
Barcelona, España AstraZeneca GmbH A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
-
Senior Regulatory Affairs Director
hace 4 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional...
-
Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España FARMAPROJECTS SAU A tiempo completoFarmaprojects SAU is a B2B Pharmaceutical Laboratory company offering a broad portfolio of generic pharmaceutical products and value-added medicines. We are looking for a Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department.Key responsibilities include:Developing assessments and strategic regulatory plans for strategic product...
-
Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Werfen A tiempo completoThe Regulatory Affairs department at Werfen is seeking a highly skilled Quality and Regulatory Affairs specialist to join our team in Barcelona, Spain.As a Quality and Regulatory Affairs specialist, you will be responsible for supporting the execution of pre and post-market regulatory affairs departmental functions. This includes assisting in the preparation...
-
Senior Regulatory Affairs Specialist
hace 1 mes
Barcelona, España Grifols A tiempo completoSenior Regulatory Affairs Specialist Barcelona 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 1909 has been working to improve the health and well-being of people around the world. We are leaders in...
-
Regulatory Affairs Senior Director of Quality
hace 4 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Description: As a Regulatory Affairs Senior Director of Quality, you will lead and manage a team of regulatory professionals within the Regulatory API (RAPI) department, driving the delivery of high-quality documentation to support successful submissions to regulatory authorities. Your key responsibilities include:
-
Senior Regulatory Affairs Specialist
hace 2 semanas
Barcelona, España Grifols A tiempo completoSenior Regulatory Affairs Specialist Barcelona 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 1909 has been working to improve the health and well-being of people around the world. We are leaders in...
