REGULATORY AFFAIRS ENGINEER (PRE-MARKET)

The RoleSinclair is currently looking for a Regulatory Affairs Engineer at its offices located in Esplugues del Llobregat (Barcelona). The role could be hybrid or remote. This is initially to support a 12-month project so we will consider an in-house contract or collaboration as an external consultant.Working within the Corporate Regulatory Affairs Team, the Regulatory Affairs Engineer ensures regulatory requirements are met for new product development, design changes and legacy devices. Supporting operations and business needs to ensure product compliance.Reporting to the RA Team Leader, the Regulatory Affairs Engineer assures the Sinclair EBD products comply with the regulatory requirements and state of the art and supporting evidence gathered appropriately.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 with the UK, European, USA, and International country-specific legislations.This position will prepare dossiers and technical documentation for product submissions worldwide. This position will be responsible for the management of the submission with the regulatory agency.About SinclairFounded in 1971, Sinclair is a global medical aesthetics organization, 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 VisionProviding aesthetic excellence globally.Our MissionDriving the advancement of product quality and customer satisfaction, investing in innovation and people.Our ValuesAct with IntegrityBe results drivenEmbrace your winning spiritStay ahead of the gameOne team, one goalKey Responsibilities:To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in EU, US, UK, and Canadian territoriesPreparation of technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategyEstablish and maintain regulatory information systems, technical documentation files, and routine reportsCollaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and proceduresEnsure regulatory compliance with global requirements and company policiesReview documents and product changes for regulatory submission impactTo provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilitiesReview and approve product artworks and relevant marketing materials according to Sinclair strategies and any applicable regulatory requirements or standardTo identify, deliver, and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairsLiaise with and assist the vigilance team and risk management team concerning requirements of product dossiers and relevant post-marketing activities as and where necessaryAssist and support inspections and auditsLiaise with, assist, and support in the creation of the QMS process for regulatory aspects. Responsible for the local implementation and training of the regulatory processDeputise for Manager as required.Your Skills & Experience – Do You Have What it Takes?Essential:Bachelor's degree in Electronic/Mechanical Engineering, Biomedical Engineering.Minimum 4-5 years experience in Regulatory Affairs (Pre-Market) within a Medical Devices organization.Mandatory RA experience with energy-based devices / active medical devices.Working knowledge of the Medical Device Regulation and Medical Device DirectiveKnowledge of other regulatory legislation and guidelines, e.g., US, Canadian regulationsExcellent attention to detail when reviewing and preparing documentation.Organised, target-orientated, flexible, good time management skillsStrong written and oral communication skillsFluency in written and spoken English.Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304)Specific knowledge ISO 13485Desirable:Specific knowledge in dermatology/aestheticsSpecific knowledge of material compliance regulatory requirements (e.g. RoHS, REAC, POP, Prop 65)Experience writing Clinical Evaluation Reports (CEP/CER’s)Knowledge about risk management activities (e.g. ISO 14971).MDSAP KnowledgeA bit about you – do you fit this description?Able to work autonomously and proactively.Communication, impact and influenceAnalytical and critical thinking capacityTime management, organization, and planningWork accurately with attention to detail and promote a quality culture throughout the business.Orientation towards achievementAdaptability and openness to changeAbility to learnIntegrity and professional ethicsCross-disciplinary cooperationThis is an exciting opportunity to join a successful company, with big ambitions for the future.If this sounds like you and you meet the requirements, please apply, we would love to hear from you.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.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 the Terms & Conditions associated with the use of such CVs will be considered null and void.We are equal opportunity employers and maintain affirmative action plans to recruit, retain, develop, and promote qualified individuals without unlawful consideration of race, gender, color, religion, sexual orientation, gender identity, national origin, age, disability, citizenship status, veteran status, or any other characteristic protected by federal, state or local law. We strive to maintain a work environment free from unlawful discrimination and harassment, where employees are treated with respect and dignity.