Quality Assurance and Regulatory Affairs Coordinator
Linkocare Life Sciences AB / Biomedicinjobb / Solna
2025-12-17
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hela Sverige LinkoCare Life Sciences AB is a pioneering Swedish med-tech company working at the forefront of tissue engineering and bioengineered implantable medical devices for ocular applications.
As an innovative, research-driven start-up, we are committed to developing transformative solutions for corneal repair and vision restoration.
We are now seeking a QA/RA Coordinator to join our team in Solna. This is a key role within the organization and a great opportunity for someone with 2-3 years of experience in a similar position within the medical device industry who is ambitious, detail-oriented, and eager to grow.
About the Role
The QA/RA Coordinator plays a central part in driving our culture of continuous improvement. Working closely with the QA/RA Manager, you will support the development, maintenance and improvement of our Quality Management System and regulatory processes. You will be involved in a wide variety of cross-functional activities and contribute directly to LinkoCare's compliance, product quality, and overall business success.
This is a hands-on, broad, and impactful role suited to someone who thrives in a small, agile, R&D-focused environment.
Key Responsibilities
• Maintain and update the Quality Management System, ensuring implementation, compliance, follow-up and continuous improvement.
• Participate in all quality-influencing processes including deviation handling, CAPA, change control, and risk management.
• Support internal and external inspections and audits.
• Assist with incident reporting and regulatory communication.
• Work with the QA/RA Manager to maintain technical documentation, including clinical evaluations.
• Support the Risk Management process in accordance with EU MDR and ISO 14971.
• Support implementation of Post-Market Surveillance activities in collaboration with Sales/Marketing.
• Build strong cross-functional relationships and promote high standards of quality and compliance across the organisation.
• Follow LinkoCare's core values, policies, and internal guidelines, and escalate risks or concerns when required.
Qualifications & Competencies
Essential
• University degree in Engineering, Medical Sciences, Quality Engineering or another relevant discipline.
• 2-3 years of experience in a QA/RA role within the medical device industry.
• Working knowledge of key regulatory frameworks such as EU MDR 2017/745, FDA 21 CFR 820, ISO 13485 and ISO 14971.
• Strong communication skills in both written and spoken English.
• Highly organised, structured and detail oriented.
• Analytical mindset with strong problem-solving abilities.
• Ability to build strong internal and external relationships.
• Self-driven, responsible and committed to delivering high-quality results.
Desirable
• Experience working in a start-up or R&D-driven environment.
• Experience supporting high-risk (Class III) medical device development or manufacturing.
• Experience with process improvement or development projects.
• Knowledge of ocular or implantable devices is an advantage.
Why Join LinkoCare?
• Be part of a visionary company developing next-generation implantable devices with global impact.
• Work closely with world-leading engineers and scientists in a collaborative, innovative environment.
• Play an active role in shaping quality and regulatory systems during an exciting growth phase.
• Competitive salary and benefits, with strong opportunities for professional development.
Start date
Early 2026
Application procedure
Apply for the position by submitting a copy of your CV, a letter of interest, and any supporting documents including your university degree certificate, recommendation letters, awards and other credentials and certificates, etc. to the company's HR Manager, Ms. Shideh Tabe at email address below:
shtabe@linkocare.comAlso, turn to the same address for more information or if you have any questions regarding the position or the company.
Looking forward to receiving your application!
To learn more about what we do at LinkoCare Life Sciences AB please visit:
http://www.LinkoCare.comLinkoCare Life Sciences AB is an equal opportunity employer. We are committed to ensuring equality, diversity, and inclusion in our workforce. Accordingly, we strongly encourage applications from visible minorities, women, as well as from all qualified candidates with the skills and knowledge to productively engage with equitable, diverse, and inclusive communities.
Så ansöker du Sista dag att ansöka är 2026-01-04
E-post:
shtabe@linkocare.com Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "Regulatory".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Linkocare Life Sciences AB (org.nr 556947-8398)
Jobbnummer 9650106