The Quality Manager and Regulatory Specialist will lead the development, implementation, and maintenance of our Quality Management System (QMS) and Technical Documentation for hardware and software medical devices.

Your responsibilities

Develop and implement.

• Develop and implement our Quality Management System (QMS) to comply with regulations and standards, such as ISO 13485 and FDA requirements.
• Ensure that our medical device products comply with regulatory requirements, including the development of our product’s Technical Documentation.

Communicate, manage and train.

• Be the go-to person for the internal product development team and external consultants about regulatory and quality matters.
• Manage relationships with external partners, including contract manufacturers and suppliers, to ensure compliance with regulatory requirements.
• Prepare and submit regulatory submissions to regulatory authorities for product clearance or approval.
• Be the contact point for and coordinate with external auditors, such as regulatory or certification bodies, to facilitate audits of the QMS and other communication.
• Provide training on quality-related and regulatory-related topics to employees across the organisation.

Maintain, improve and grow.

• Ensure the QMS is effectively maintained, improved, and properly documented throughout the organisation.
• Ensure that the QMS and regulatory processes are integrated into the overall business strategy and that quality and regulatory compliance are key considerations in all business decisions.
• Develop regulatory strategies for new products or modifications to existing products, including identifying and addressing potential regulatory issues.
• Maintain knowledge of regulatory changes and updates and communicate the impact of these changes to our leadership team.

Who you are

• You have a Bachelor's degree in a relevant field, such as engineering, science, or regulatory affairs.
• You want to work in a high-performance organisation and get stuff done.
• You are not afraid of orchestrating the work of external consultants. You see this as a growth opportunity.
• You have strong oral and written communication skills.
• You can work independently and as part of a team.
• Experience in quality management and regulatory affairs for medical devices is a plus but not a must. Junior applicants are welcome.

What do we offer

• The opportunity to impact the outcome of the company.
• Interesting and challenging work.
• Flexible working hours and minimal meeting culture.
  
• A competitive remuneration.
  
  

At Zaamigo, we value diversity. As an equal opportunity employer, we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.