Quality and Regulatory Affairs Manager
Posted 05/04/2024 by 5Values
Remote job
Senior Quality and Regulatory Affairs Manager
Permanent contract
Remote, office located in Berlin, Germany - Must travel on-site once a month
Up to €80 000
Are you an experienced QA Manager with experience in regulatory affairs and ISO?
Do you enjoy working in med-tech?
Then this position is made for you!
5V Tech is proud to be working in partnership with a company in Berlin, who are at the forefront of innovative fem-tech. They are a passionate team of visionaries and engineers looking to revolutionise med-tech, in particular linked to women health.
Though this position is remote, you will have to be able to travel to the Berlin office once a month, and therefore be in the EU area.
Duties:
- Take care of the implementation and maintenance of a Quality Management System (QMS) that complies with ISO 13485, ISO 14971, IVDR and FDA 510(k)
- Ensure that the processes and products meet all necessary quality and regulatory requirements before they reach the users
- (In English, though it could also be in German) Communicate with Notified Body and other responsible authorities
- Ensure documentation is always kept up-to-date
Requirements:
- Proven experience with managing QM systems in accordance with ISO related to med-tech such as 13485, ISO 14971 (or ISO 9001) and FDA
- Experience with regulatory affairs for medical devices and QMS
- Knowledge of, or experience with, in-vitro diagnostic medical devices regulation (MDD / MDR) IVDR and CFR
- Exceptional communication skills, attention to detail and project management experience or knowledge
Nice to have:
- Experience in med-tech / fem-tech
- Able to speak German to B1/B2 level
- Start-up mindset
Apply now to get full details!
5V Tech are acting as an Employment Agency for the purposes of this job vacancy. We offer a reward scheme if you can recommend someone for this position, up to £250 for you and an additional £250 to a charity of your choice, 5V Tech are recognised talent solutions experts within IoT and Deep Tech working across Europe, the UK and North America.
Permanent contract
Remote, office located in Berlin, Germany - Must travel on-site once a month
Up to €80 000
Are you an experienced QA Manager with experience in regulatory affairs and ISO?
Do you enjoy working in med-tech?
Then this position is made for you!
5V Tech is proud to be working in partnership with a company in Berlin, who are at the forefront of innovative fem-tech. They are a passionate team of visionaries and engineers looking to revolutionise med-tech, in particular linked to women health.
Though this position is remote, you will have to be able to travel to the Berlin office once a month, and therefore be in the EU area.
Duties:
- Take care of the implementation and maintenance of a Quality Management System (QMS) that complies with ISO 13485, ISO 14971, IVDR and FDA 510(k)
- Ensure that the processes and products meet all necessary quality and regulatory requirements before they reach the users
- (In English, though it could also be in German) Communicate with Notified Body and other responsible authorities
- Ensure documentation is always kept up-to-date
Requirements:
- Proven experience with managing QM systems in accordance with ISO related to med-tech such as 13485, ISO 14971 (or ISO 9001) and FDA
- Experience with regulatory affairs for medical devices and QMS
- Knowledge of, or experience with, in-vitro diagnostic medical devices regulation (MDD / MDR) IVDR and CFR
- Exceptional communication skills, attention to detail and project management experience or knowledge
Nice to have:
- Experience in med-tech / fem-tech
- Able to speak German to B1/B2 level
- Start-up mindset
Apply now to get full details!
5V Tech are acting as an Employment Agency for the purposes of this job vacancy. We offer a reward scheme if you can recommend someone for this position, up to £250 for you and an additional £250 to a charity of your choice, 5V Tech are recognised talent solutions experts within IoT and Deep Tech working across Europe, the UK and North America.
- Type:
- Permanent
- Start Date:
- 04/04/2024
- Contract Length:
- N/A
- Contact Name:
- Login or register to view
- Telephone:
- Login or register to view
- Job Reference:
- BH-13875
- Job ID:
- 221425292
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