Regulatory Affairs and Quality Assurance Manager

Grant Alexander; Jura; On-site; CHF 110,000 - 140,000; Full time

Job summary

Grant Alexander is recruiting an experienced Regulatory Affairs & QA leader for a hands-on role in the medical-device dental sector. You will own regulatory and quality processes, drive improvement initiatives, and collaborate with R&D, management, suppliers, and external authorities.

You will create and maintain Technical Files, manage international submissions, lead audits, and oversee QMS and vigilance. Fluency in English with French or German a plus is preferred.

Qualifications

• Degree in engineering, natural sciences or a related discipline.
• 5–8 years of experience in Regulatory Affairs and Quality Assurance within a medical-device manufacturer; exposure to the dental industry is an advantage
• Strong knowledge of relevant national and international standards and regulations
• Hands-on experience with Technical Files, regulatory submissions, audits, QMS, complaint handling and vigilance
• Experience with electronic quality management and complaint-handling systems
• Fluent in English; French and German of advantage

Responsibilities

• Create and maintain Technical Files and manage international regulatory submissions.
• Manage interactions with notified bodies and regulatory authorities.
• Provide regulatory guidance and support to R&D for new product development and product improvements.
• Act as the main internal and external contact for regulatory and quality matters.
• Monitor changes in applicable regulations and standards and translate them into practical guidance and training.
• Prepare and coordinate audits by authorities and notified bodies and represent management during audits.
• Conduct supplier audits.
• Oversee incoming inspection and final product release, including redesign of incoming inspection processes.
• Lead complaint investigations and strengthen related quality processes.
• Establish, maintain and continuously improve the Quality Management System (QMS).
• Set up and maintain the vigilance system and related electronic workflows.

Skills

Regulatory Affairs

Quality Assurance

Audits

QMS

Regulatory submissions

Technical Files

Vigilance

Complaint handling

Supplier audits

eQMS

Cross-functional collaboration

English

French

German

Education

Engineering degree

Natural sciences degree

Related discipline

Tools

eQMS software

Regulatory databases

Job description

Are you an experienced Regulatory Affairs & Quality Assurance professional looking for a hands-on role within the medical-device industry, combining operational responsibility with improvement and development projects?

For our client, a growing player in the dental industry, we are looking for an experienced RA/QA professional to take a key role in strengthening the regulatory and quality framework, supporting product development and ensuring compliance across the product lifecycle.

You will work closely with R&D, management and external partners, combining regulatory expertise with practical ownership of quality processes and systems.

Your responsibilities

As the RA/QA lead, you will be responsible for identify areas for improvement and turn regulatory and quality requirements into effective, workable processes. Your responsibilities include but are not limited to:

• Creating and maintaining Technical Files and managing international regulatory submissions
• Managing interactions with notified bodies and regulatory authorities
• Providing regulatory guidance and support to R&D for new product development and product improvements
• Acting as the main internal and external contact for regulatory and quality matters
• Monitoring changes in applicable regulations and standards and translating them into practical guidance and training
• Preparing and coordinating audits by authorities and notified bodies and representing management during audits
• Conducting supplier audits
• Overseeing incoming inspection and final product release, including the redesign of incoming inspection processes where required
• Leading complaint investigations and strengthening related quality processes
• Establishing, maintaining and continuously improving the Quality Management System (QMS)
• Setting up and maintaining the vigilance system and related electronic workflows

What we're looking for

You are a hands-on, structured and pragmatic RA/QA professional who is comfortable taking ownership and working across functions. You combine sound regulatory knowledge with a practical approach to quality management and enjoy working closely with R&D, management, suppliers and external regulatory bodies.

• Degree in engineering, natural sciences or a related discipline
• 5–8 years of experience in Regulatory Affairs and Quality Assurance within a medical-device manufacturer; exposure to the dental industry is an advantage
• Strong knowledge of relevant national and international standards and regulations
• Hands-on experience with Technical Files, regulatory submissions, audits, QMS, complaint handling and vigilance
• Experience with electronic quality management and complaint-handling systems
• Fluent in English; French and German of advantage