Senior Regulatory Affairs Engineer

hace 2 meses

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 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 recruitment@sinclair.com.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 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.
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