RA & QA Compliance Specialist.

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

We are seeking a qualified candidate for the role of Regulatory Affairs and Quality Assurance Specialist. This position is integral to ensuring compliance with the EU Medical Device Regulation (EU MDR), Swiss Medical Devices Ordinance (Swiss MedDO), and relevant regulatory standards.

Key responsibilities include:

• Supporting the Regulatory Surveillance process to monitor local EU regulations.
• Participating in process improvement initiatives to enhance regulatory processes and Quality Management System (QMS) procedures.
• Assisting with documentation change control management and record keeping.
• Collaborating with the Change Control department to provide guidance on change control and documentation.
• Contributing to the development of training materials on compliance topics.
• Supporting various Quality Management System activities, including Corrective and Preventive Actions (CAPA), quality plans, and audits.

Qualifications:

• Strong knowledge of EU Medical Device Regulation (EU) 2017/745, European Medical Device Directive 93/42/EEC, and Swiss Medical Device Regulation (MedDO).
• Familiarity with product EU regulations and directives.
• Proficiency in computer literacy, including Microsoft Word, Excel, PowerPoint, and Outlook.
• 3-5 years of experience in Medical Device Quality or regulatory compliance/Quality system roles.
• A Bachelor’s or Master’s degree in medical technology, life sciences, or a related field (or equivalent work experience).
• Experience in documentation control and record management is preferred.
• Excellent organizational, problem-solving, and interpersonal skills.
• Fluent written and spoken English (C1 minimum).

Preferred Experience:

Knowledge of US FDA 21 CFR 803/806/820 would be advantageous.

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