RA & QA Compliance Specialist

Jobdescription

Are you ready to dive into the world of RegulatoryAffairs and Quality Assurance ? We're on the lookout for a RA &QA Compliance Specialist to join a dynamic team and medical devicecompany !

We are seeking aqualified candidate for the role of Regulatory Affairs and QualityAssurance Specialist. This position is integral to ensuringcompliance with the EU Medical Device Regulation (EU MDR), SwissMedical Devices Ordinance (Swiss MedDO), and relevant regulatorystandards.

Keyresponsibilities include :

• Supportingthe Regulatory Surveillance process to monitor local EUregulations.
• Participating in processimprovement initiatives to enhance regulatory processes and QualityManagement System (QMS) procedures.
• Assistingwith documentation change control management and recordkeeping.
• Collaborating with the Change Controldepartment to provide guidance on change control anddocumentation.
• Contributing to the developmentof training materials on compliancetopics.
• Supporting various Quality ManagementSystem activities, including Corrective and Preventive Actions(CAPA), quality plans, andaudits.

Qualifications :

• Strongknowledge of EU Medical Device Regulation (EU) 2017 / 745, EuropeanMedical Device Directive 93 / 42 / EEC, and Swiss Medical DeviceRegulation (MedDO).
• Familiarity with product EUregulations and directives.
• Proficiency incomputer literacy, including Microsoft Word, Excel, PowerPoint, andOutlook.
• 3-5 years of experience in MedicalDevice Quality or regulatory compliance / Quality systemroles.
• A Bachelor’s or Master’s degree inmedical technology, life sciences, or a related field (orequivalent work experience).
• Experience indocumentation control and record management ispreferred.
• Excellent organizational,problem-solving, and interpersonalskills.
• Fluent written and spoken English (C1minimum).

PreferredExperience :

Knowledge of US FDA 21 CFR803 / 806 / 820 would beadvantageous.

Ifyou meet the qualifications and are interested in joining our team,please submit your application. We look forward to hearing fromyou.