Job Description

Company Overview:Join a forward-thinking UK-based company revolutionizing the way businesses connect with remote talent. Our innovative team, driven by creativity and dedication, is pioneering new ways of thinking in remote hiring. We are committed to fostering a collaborative environment that values innovation and growth.Job Overview:We are seeking a highly skilled and experienced Medical Device Quality Assurance and Regulatory Affairs (QARA) Consultant to join our team. This role involves providing expert consultation and support to navigate the complex landscape of medical device regulations and quality assurance requirements. The ideal candidate will collaborate with internal teams and external stakeholders to ensure compliance with regulatory standards and maintain the highest level of product quality and safety. This is a fully remote role.Working Hours:Monday to Friday, 9:00 AM - 5:30 PM BST(5-day working week)Key Responsibilities: * Regulatory Compliance:Interpret and stay updated on European and UK regulatory requirements related to medical devices, including EU Medical Device Regulation (MDR), UKCA (UK Conformity Assessed marking), and ISO 13485 standards.Assess the impact of regulatory changes on current and future product offerings and provide strategic guidance to ensure compliance. * Quality Assurance:Develop, implement, and maintain quality management systems (QMS) in accordance with applicable regulatory standards.Conduct internal audits and assessments to identify areas for improvement and ensure adherence to QMS requirements.Provide guidance on quality control processes, including risk management, CAPA (Corrective and Preventive Actions), and complaint handling. * Regulatory Submissions:Prepare and review regulatory submissions, including CE marking applications and other relevant regulatory filings.Coordinate with regulatory agencies and notified bodies to facilitate the approval and clearance of medical devices. * Product Development Support:Collaborate with cross-functional teams during product development to ensure regulatory requirements are considered from concept to commercialization.Review design control documentation, including design inputs, verification, and validation protocols, to ensure compliance with regulatory standards. * Training and Education:Provide training and guidance to internal stakeholders on regulatory requirements, quality standards, and best practices in QARA.Stay abreast of industry trends and disseminate relevant information to the organization to facilitate continuous improvement.Qualifications:Bachelor's degree in a relevant scientific or engineering field (e.g., Biomedical Engineering, Chemistry, Biology) required; advanced degree preferred.Minimum of 5+ years of experience in medical device regulatory affairs and quality assurance with a demonstrated track record of successful regulatory submissions and compliance.In-depth knowledge of EU MDR, UKCA, ISO 13485, and other international regulatory requirements for medical devices.Strong analytical and problem-solving skills with the ability to interpret complex regulatory guidance and develop practical solutions.Excellent communication skills with the ability to effectively interact with internal teams, external partners, and regulatory authorities.Certification such as RAC (Regulatory Affairs Certification) or ASQ (American Society for Quality) certification is desirable.

Remote Recruitment