QA/RA officer
Are you a proactive, motivated professional in Regulatory Affairs (RA) and Quality Assurance (QA) within the medical device industry? Do you have a passion for guiding a scale-up through complex regulations and quality standards such as MDR, ISO 13485, FDA guidance’s and perhaps some affinity with the ISO 27001? If so, we are looking for you!
As a QA/RA Officer in our medical company, you will provide strategic advice to our management team and operational support to our R&D team, Operations and (certified) suppliers. You will help navigate the ever-evolving regulatory landscape and ensure compliance with the highest quality standards. Your role is crucial in guaranteeing the safety and compliance of our products and services, making a significant contribution to improve patient care and supporting healthcare professionals.
About smartQare
smartQare is a young health technology company with driven professionals who have a common mission: to contribute with smart solutions to a world with good care, where and when it is needed. A world in which healthcare is accessible and affordable, and attractive to work in. A world in which people can maintain as much autonomy as possible for as long as possible, so that they can continue to do what really matters to them.
Your responsibilities
- Regulatory Compliance: Stay up-to-date with regulations including MDR (Medical Device Regulation), ISO 13485, and FDA guidelines.
- Quality Management: Manage and optimize our Quality Management System (QMS).
- Compliance Oversight: Ensure our solutions comply with European and U.S. regulations.
- Documentation: Prepare and maintain technical documentation and risk assessments; support R&D teams as a quality engineer.
- Audits: Prepare for and lead internal and external audits; resolve CAPAs, manage tickets, optimize processes, and drive quality improvements.
- Collaboration: Work closely with the management team, organize management reviews, support the R&D team and operations on quality engineering topics, and liaise with external (certified) suppliers.
- Reporting: Provide reports to our management on quality and compliance matters.
- Training: Train the smartQare team to enhance knowledge of quality and regulatory requirements.
- PMS & PMCF: Support the development and implementation of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) processes and reviews.
What we offer
- primary employment benefits
- 32 to 40 hours per week.
- Flexible working arrangements.
- Salary based on experience and qualifications.
- Participation in the smartQare Stock Appreciation Rights (SAR) program.
- 25 vacation days (based on a full-time 40-hour workweek), with the option to purchase additional days.
What you bring
- A bachelor’s or master’s degree in a relevant field (e.g., Biomedical Sciences, Medical Technology, Information Technology, or Pharmacy).
- At least 5 years of experience in Regulatory Affairs and Quality Assurance within the medical device industry.
- Strong knowledge of relevant regulations such as MDR, ISO 13485, and FDA CFR Title 21.
- Experience in coordinating audits, preparing technical documentation, and submitting CE and 510(k) applications.
- Excellent communication and project management skills.
- Ability to work independently and proactively provide guidance to the management team and suppliers.
- Fluency in Dutch and English (spoken and written).
Why work at smartQare?
Beyond the diverse projects and our mission to shape the future of healthcare, working at smartQare offers even more advantages. We operate across multiple countries, presenting exciting challenges in regulatory compliance, connectivity, and hospital implementation. You will never have a dull moment!
Check out our company values at www.smartqare.com/about-smartqare
Grow with us
Based on your skills and ambitions, we will help you find the right training to keep you up to date with the latest developments in medical regulations and quality systems.
Interested?
We would love to hear from you! Send your CV to: hr@smartqare.com.