Lead Quality & Regulatory Excellence in a Growing MedTech Company

Smartz AG, a global purpose built Swiss Company focused on delivery world leading Smart Wearable Technology is seeking an experienced Quality & Regulatory Affairs (QARA) Manager to lead the development, implementation and continuous improvement of our Quality Management System and Regulatory Affairs functions. This is a remote work from home opportunity.

This is a unique opportunity to join an innovative medical device company at an exciting stage of growth, where you will play a critical role in bringing new technologies to market while ensuring compliance with global regulatory requirements.

Reporting directly to the Chief Technology Officer, you will work across product development, quality, regulatory strategy and commercialisation, helping shape the future of our products and quality culture.

About the Role

As QARA Manager, you will be responsible for maintaining and enhancing our Quality Management System (QMS), managing regulatory submissions and approvals, supporting product development activities, and ensuring compliance across all aspects of the business.

Key responsibilities include:

Quality Management Systems

Act as Management Representative for the QMS

Maintain and continuously improve the QMS in accordance with ISO 13485

Lead internal audits, management reviews and quality improvement initiatives

Manage CAPA, non-conformances, deviations, change control and document control processes

Coordinate external audits, certification audits and regulatory inspections

Regulatory Affairs

Develop and execute regulatory strategies for global market access

Manage product registrations and regulatory approvals

Liaise with regulatory authorities, Notified Bodies, consultants and authorised representatives

Monitor regulatory changes and assess impacts on products and business operations

Provide expert regulatory guidance across the organisation

Product Development & Compliance

Support design and development activities in accordance with design control requirements

Review verification, validation and design transfer activities

Ensure technical documentation complies with applicable regulatory requirements

Support product commercialisation from concept through to market launch

Technical Documentation & Risk Management

Prepare and maintain Technical Files, STEDs, DHFs and DMRs

Lead risk management activities in accordance with ISO 14971

Maintain FMEA, risk analyses and risk management plans

Support regulatory submissions and certification activities

Post-Market Surveillance & Supplier Quality

Manage PMS, PMCF, complaints and vigilance reporting

Lead supplier qualification and supplier audit activities

Support contract manufacturers and quality agreements

Drive continuous improvement initiatives throughout the product lifecycle

About You

You are a quality and regulatory professional who thrives in a dynamic environment and enjoys working collaboratively across engineering, product development and leadership teams.

Essential Skills & Experience

Minimum 5 years' experience in Quality Assurance and/or Regulatory Affairs within the medical device industry

Strong knowledge of:

ISO 13485

ISO 14971

EU MDR 2017/745

UK MDR / UKCA

TGA Medical Device Regulations

FDA QMSR (21 CFR 820)

Experience managing and improving Quality Management Systems

Experience preparing and maintaining technical documentation and regulatory submissions

Strong understanding of design controls, risk management and post-market surveillance

Experience managing internal and external audits

Experience supporting or leading Class II medical device submissions and registrations

Desirable

Experience with active medical devices, wearables or Software as a Medical Device (SaMD)

Familiarity with AI/ML-enabled medical devices

Experience implementing electronic Quality Management Systems (eQMS)

ISO 13485 Lead Auditor certification and/or Regulatory Affairs Certification (RAC)

Experience building a QMS from the ground up

Experience leading and mentoring team members

Why Join Us?

Opportunity to influence the quality and regulatory strategy of an innovative MedTech business

Work on cutting-edge medical technologies, including connected health and software-enabled products

Collaborative and highly skilled team environment

Flexible working arrangements

Competitive remuneration package

Career growth and leadership opportunities

Apply Now

If you are passionate about quality, regulatory excellence and bringing innovative healthcare technologies to market, we would love to hear from you.

Please submit your CV and a brief cover letter outlining your relevant experience and regulatory expertise.

Applications will be treated confidentially.