Spermosens AB is developing a revolutionary platform technology for diagnosing male-factor infertility and directing to the right infertility treatment. The company is in an expansive phase and growing quickly.
Spermosens is now looking for a Quality Assurance & Regulatory Affairs Manager to our head office at Medicon Village in Lund. You will join a tightly knit team driven by our companies Vision – To improve the Quality of Life for couples with infertility problems around the world. This is an opportunity to grow within Spermosens and be a part of our daily decision-making processes.
At Spermosens we highly value collaboration, inclusion and diversity in our team and we think it is very important to have a good time at work.
For more information about us please visit http://www.spermosens.com/.
In this position you will coordinate and supervise the implementation of the Quality Management System. You will also align the external and internal process and manage audits. You will be the Responsible person.
Furthermore you will:
- Establish and update SOPs, quality documents and templates
- Ensure compliance with developing partners
- Streamline regulatory processes
- Manage deviation reports
- Handle documentation of technical files
- Be responsible for planning and execution of supply audit
- Communicate with Regulatory consulting firms for support
- Perform data analysis for reporting
- Strategise regulatory pathways
Education and Experience
- A relevant post-secondary education, for example a Bachelor or Master in Science or Engineering.
- At least two years’ experience from working in a similar position
- A good knowledge of ISO 13485:2016 and IVDD/IVDR or MDR
- Excellent communication skills, both written and verbal English
- A good knowledge in Excel and the Office suite
- Knowledge of working in Cloud
- A good knowledge and experience from working in a Quality Management System
As a person you have the ability to work in a team and share responsibilities and tasks. You are well organised, structured with a good planning ability. You are good at writing and reporting in a well-structured and logical way. Also, we think that you as person is prestigeless, stress resistant, positive and flexible with an ability to handle many projects at the same time. Finally, you keep to schedules and follow procedures and policies.
As a Quality Assurance & Regulatory Affairs Manager you will report to our CSO. This is a full time position at our head office in Lund. Eventually there could be some travelling days.
For questions regarding this position please contact our Recruitment consultant Pernilla Agardh at +46 72 249 94 80. We will evaluate the applications on an ongoing basis so please don’t wait too long sending it.