![Covartim](https://media.trabajo.org/img/noimg.jpg)
Clinical Affairs Manager
il y a 2 semaines
Functieomschrijving:
The Clinical Affairs Manager shall provide support for the development of innovative medical devices, as part of the development team within COVARTIM.
- Preparation of CEP and CER
- Management of clinical investigation
- Set up and follow up of PMS, PMCF, PSUR
- Review and preparation of documentation packages for notified bodies, FDA, competent authorities
Location
Boulevard du Souverain 36, 1170 Watermael-Boitsfort (Brussels)
Function type
Full time open-ended
Background:
Min. 3 years of relevant experience in Medical Devices QA/RA functions.
Hard skills:
- Good understanding of medical devices and IVD regulatory environment
- Good knowledge of medical devices clinical investigation clearance process (EU and US)
- Good knowledge of medical devices risk management, CIP, CIR, CEP, CER, PMS, PMCF, PSUR
- English and French/Dutch
Soft skills:
- Passionate about Lifesciences, technology and innovation
- Quality and customerservice oriented
- Strong communication and organizational skills
- Autonomous & Quick learner
- Flexible & openminded
- The opportunity to contribute to the development of products that will improve or save people's life
- A valorizing job within an ambitious and growing company in a booming industry
- A great team of enthusiastic people led by passionate experts in MedTech
- A nice working environment in our new office located in Brussels, close to the forest of Soignes, a park, nice shops and restaurants, public transport connections and the E41
- And of course, a good salary package and extra benefits
Managing Director
-
QA/ra Manager
il y a 2 semaines
Watermael-Boitsfort, Région de Bruxelles, Belgique Covartim Temps pleinFunctieomschrijving:The QA/RA Manager shall provide support for the development of innovative medical devices, as part of the COVARTIM QA/RA team.(S)he will manage Quality Assurance and Regulatory Affairs activities such as, but not limited to: Quality Management System implementation Standards watch and gap analysis Audits (internal/external) Review and...
-
QA / Ra Development Team Manager Medtech
il y a 2 semaines
Watermael-Boitsfort, Région de Bruxelles, Belgique Walter Welton Temps pleinOur client is a Belgian engineering company specializing in the development of medical devices, IVD medical devices, and medical software. Based in Brussels, our client's focus extends to BeNeLux, France, and the US.Founded in 2016, our client emerged with the aim of providing comprehensive solutions to entrepreneurs and SMEs, supporting them in bringing...
-
QA/ra Associate
il y a 2 semaines
Watermael-Boitsfort, Région de Bruxelles, Belgique Covartim Temps pleinFunctieomschrijving:The QA/RA Associate shall provide support for the development of innovative medical devices, as part of the COVARTIM QA/RA team.(S)he will provide support in Quality Assurance and Regulatory Affairs activities such as, but not limited to: Quality Management System implementation at our clients site Standards watch and gap analysis Audits...
-
Internal & External Affairs Manager
il y a 4 semaines
Watermael-Boitsfort, Belgique Tajo Temps pleinTAJO staat voor Talentatelier voor jongeren: jongeren uit kwetsbare situaties krijgen een inkijk in wat ‘later’ zoal in petto heeft, opdat ze het belang van leren en ‘je best doen voor later’ beter begrijpen en daardoor gemotiveerd worden om te studeren.Hiervoor organiseert TAJO ervaringsleren in een driejarige cyclus a rato van 25 zaterdagen...
-
QA / Ra Development Team Manager Medtech
il y a 5 jours
Bruxelles Watermael-Boitsfort, Belgique Walter Welton Temps pleinOur client is a Belgian engineering company specializing in the development of medical devices, IVD medical devices, and medical software. Based in Brussels, our client's focus extends to BeNeLux, France, and the US. Founded in 2016, our client emerged with the aim of providing comprehensive solutions to entrepreneurs and SMEs, supporting them in bringing...