Senior Quality and Regulatory Affairs Specialist

Asks for

• CAPAsThe ad says“Proficiency in quality management systems (QMS), including the development and maintenance of procedures, work instructions, CAPAs, audit support activities, and regulatory compliance documentation.”
• compliance tracking systemsThe ad says“Strong analytical and project management skills, with experience using regulatory databases and compliance tracking systems to manage regulatory commitments, metrics, risk assessments, and continuous improvement initiatives.”
• device registrationsThe ad says“Hands-on experience supporting device registrations, technical documentation reviews, authorised representative activities, and regulatory submissions within the medical device industry.”
• Economic Operator obligationsThe ad says“Strong knowledge of EU MDR (2017/745), IVDR (2017/746), UK Medical Device Regulations, and Swiss regulatory requirements, including Economic Operator obligations for Authorised Representatives, Importers, and Distributors.”
• EU MDR (2017/745)The ad says“Strong knowledge of EU MDR (2017/745), IVDR (2017/746), UK Medical Device Regulations, and Swiss regulatory requirements, including Economic Operator obligations for Authorised Representatives, Importers, and Distributors.”
• gap analysesThe ad says“Experience conducting regulatory impact assessments, gap analyses, and compliance evaluations, with the ability to translate regulatory changes into actionable implementation plans.”
• IVDR (2017/746)The ad says“Strong knowledge of EU MDR (2017/745), IVDR (2017/746), UK Medical Device Regulations, and Swiss regulatory requirements, including Economic Operator obligations for Authorised Representatives, Importers, and Distributors.”
• project managementThe ad says“Strong analytical and project management skills, with experience using regulatory databases and compliance tracking systems to manage regulatory commitments, metrics, risk assessments, and continuous improvement initiatives.”
• quality management systemsThe ad says“Proficiency in quality management systems (QMS), including the development and maintenance of procedures, work instructions, CAPAs, audit support activities, and regulatory compliance documentation.”
• regulatory databasesThe ad says“Strong analytical and project management skills, with experience using regulatory databases and compliance tracking systems to manage regulatory commitments, metrics, risk assessments, and continuous improvement initiatives.”
• regulatory impact assessmentsThe ad says“Experience conducting regulatory impact assessments, gap analyses, and compliance evaluations, with the ability to translate regulatory changes into actionable implementation plans.”
• regulatory submissionsThe ad says“Hands-on experience supporting device registrations, technical documentation reviews, authorised representative activities, and regulatory submissions within the medical device industry.”
• Swiss regulatory requirementsThe ad says“Strong knowledge of EU MDR (2017/745), IVDR (2017/746), UK Medical Device Regulations, and Swiss regulatory requirements, including Economic Operator obligations for Authorised Representatives, Importers, and Distributors.”
• technical documentation reviewsThe ad says“Hands-on experience supporting device registrations, technical documentation reviews, authorised representative activities, and regulatory submissions within the medical device industry.”
• UK Medical Device RegulationsThe ad says“Strong knowledge of EU MDR (2017/745), IVDR (2017/746), UK Medical Device Regulations, and Swiss regulatory requirements, including Economic Operator obligations for Authorised Representatives, Importers, and Distributors.”