QA and RA Manager

Do you want to be a part of a small, global, and fast growing MedTech-company with the vision to win the fight against the world´s leading cause of blindness and low vision? Are you a curious and committed person who is driven by the opportunity to work with the best in the industry and to have a real impact on human health?

Then we want to hear from you!

About the Position

LinkoCare Life Sciences AB is expanding their team and is looking for a highly motivated and experienced Quality Assurance and Regulatory Affair Manager.  In this position, you will play a crucial role in ensuring the quality and regulatory compliance of their medical devices. You will be the go-to person for colleagues seeking guidance on quality and regulatory affairs and will contribute to post market surveillance and update standard operating procedures.

This is a full-time position located in Linköping Science Park with the possibility of a hybrid solution.

Responsibilities

• You have a thorough understanding of both local and international regulations and be able to develop and implement effective quality systems. 

• The position as the QA and RA Manager includes:

• be the contact person who is communicating with relevant authorities and Notified Body

• contribute to the post market surveillance and support colleagues with quality and regulatory questions as the go-to-person or subject matter expertise

• be hands on writing SOPs as well as update and implement them

• be responsible for all Quality and Regulatory affair related questions within the company

• be responsible for deviations reports

• inspire and educate all colleagues to follow the quality system

• be the company’s key person in the CE certification process

Your profile

You are a driven, detail-oriented professional with a passion for ensuring the safety and effectiveness of medical devices. You need to be able to see where the company is now and where it is going and find flexible, creative solutions to get there in a time- and price-efficient way while maintaining high quality.

Qualifications:

•  University degree in Engineering, Medical Sciences, Quality Engineering or equivalent academic relevance.  

•  Several years of experience in quality assurance and regulatory affairs from working with medical devices level 2 or 3, controlled by MDD/MDR.

•  Good understanding of applicable medical device regulations and standards.

•   Knowledge of labelling requirement within the medical device industry.

•   Able to work in a fast-paced, dynamic environment.

•   You need to have excellent writing and communication skills in English.

Beneficial

• Experience from natural based MD, IVDR and/or pharma

• Experience of working with medical device software

• Prior experience and expertise in biomaterials and tissue engineering

• Swedish communication skills.

About the organization

LinkoCare Life Sciences AB is a start-up company in Linköping Sweden mandated to manufacture bioengineered ophthalmic medical devices as well as conducting research and development in the field of bioengineering. Their mission is to offer hope and make an impact by improving vision, patient care, and life quality for the millions of people worldwide suffering from corneal and eye related diseases and conditions. The company is located in modern facilities with a beautiful view at Linköping Science Park.

In addition to a competitive salary, we offer a dynamic and innovative work environment and opportunities for professional growth and development.

 

Don’t miss this exciting opportunity to join a company that is dedicated to improving patient outcomes through cutting-edge technology. Welcome with your application today!