29 September 2023 – Job opportunity Regulatory Affairs Associate Medical Devices at Medace
About Medace
Medace is a unique service provider in the medical industry. We offer a full service ISO13485 certified work-learning environment. While being taught how to develop their medical product themselves towards clinical implementation and regulatory clearance for market introduction, clients can make use of our facilities and equipment as well as receive training and obtain advice from our experienced personnel and learn and build on our QMS template.
We offer these in configurable packages allowing our clients to adapt the support they need pending on the product development stage they are in. From access to our state-of-the-art research and cleanroom facilities and equipment, consulting on the smart way to make a compliant development and regulatory roadmap to specific regulated markets, or perhaps collaboration to build the quality management system and technical dossier needed for a clinical grade product.
Our clients range from academic groups in the ideation phase to scale-ups going through the preparations for submissions, with the focus audience consisting of startups active in the field of Medical Devices and Cell Therapy. This results in a vivid biomedical co-working space where entrepreneurship, science and professionals thrive.
As RA Associate, you are a member of the Medace Medical Device team and will be directly working with the Quality Manager Medical Devices. Mainly to provide compliance services to our clients, as well as providing feedback to continuously improve and update our QMS.
For more information about our company visit www.medacespace.com.
What are we looking for?
To work well at Medace you must have experience with not only the EU’s MDR, but also the matters that are directly and indirectly involved in complying with it, such as EN ISO 13485, the various risk management related standards, but also others such as general and collateral product standards and MDCG documents. You should be able to apply these to a wide variety of products regarding their modes of action and intended uses. When it comes to character, we look for a quick critical thinker with teaching capabilities, adaptability, and being a team player who is open to broadening their expertise over more biomedical product development areas.
Regulatory Affairs Associate Medical Devices responsibilities
- Provides advice, facilitation and training to the multi-disciplinary teams of Clients on regulatory-related processes and documentation
- Provides advice, facilitation and training to the multi-disciplinary teams of Clients on risk management related aspects
- Works with the quality and operations team to develop quality control methods relevant to client use of the facility.
- Collaborates in and on quality processes
- Help set up and conduct client and public training on compliance/quality concepts and tools.
- Support internal/external audits
Regulatory Affairs Associate Medical Devices qualifications
- At least 6 years of experience in the Medical Device industry.
- Experience in medical device compliance,
- especially EU MDR 2017/745,
- and preferably also 21 CFR Chapter I, Subchapter H.
- Ability to explain establishment of a medical device’s technical documentation by application of a QMS, including establishment of the risk management file.
- Deep knowledge of relevant standards and regulations,
- including their harmonized or consensus status,
- and preferably including experience training people on their contents and/or use.
- Adaptability for dealing with varying medical device product types.
- Experience in creating procedures/SOPs, as well as verification and validation protocols.
- Good command of English, spoken and written; preferably likewise for Dutch.
- Good communication/presentation skills.
- Team player.
What we offer
Medace offers a challenging job in an inspiring and ambitious young organization. Communication lines are short and personal initiative is highly stimulated and appreciated. We offer a market conform full-time position via a one-year contract with a possible prospect on a permanent employment. We are committed to support your professional and personal development and give you the opportunity to cooperate with talented people in an informal, transparent, and open culture. Working closely with the QA Manager will help develop your skills in advanced QA compliance, consulting, auditing, and risk management.
Interested in joining Medace as Regulatory Affairs Associate Medical Devices?
Please submit your motivation and resume via info@medacespace.com before October 30th, to be included in the first round. If you have any questions regarding this vacancy, please contact Jean Blom (QA Manager Medical Devices) via mail: jean.blom@medacespace.com or phone: +31(0)6-2545 7540.
Acquisition as a result of this vacancy is not appreciated!
Due to the characteristics of Medace, we cannot accommodate sponsorships for non-EU citizens.
