JOBS
WHY YOU SHOULD JOIN US
Facing new challenges, mastering exciting tasks in a scientific environment, developing individual solutions – that's what your job at PRO-LIANCE is all about. As a service provider for regulatory issues, we are shaping the world of tomorrow's medical devices and offer you the opportunity to actively participate in the future.
Clinical Evaluation Author (f/m/d)
We have been supporting medical device manufacturers around the world providing high-quality services in regulatory affairs since 2018. Our services help manufacturers focus on their actual core business, which is the development of medical devices. As a team, at PRO-LIANCE, we strive to be the best.
- You are a scientist at heart (university degree in science, medicine or engineering, preferably with PhD) and work with attention to detail, when required.
- Preferably you already have professional experience or regulatory training in the field of medical devices, ideally in clinical evaluation and/or regulatory affairs.
- You have a sound knowledge of all the relevant laws, guidelines and standards (in particular MEDDEV 2.7/1 and Regulation (EU) 2017/745).
- You demonstrate sufficient perseverance and tenacity to complete your tasks within the legal framework and project deadlines.
- You have an independent, structured way of working and are a team player at the same time.
- You are reliable and willing to meet expectations, have a high sense of responsibility and a service provider mentality.
- However, you are also aware of your limits and know how to communicate them.
- You are willing to discover and familiarize yourself with new topics constantly
You will take on tasks, which require a high degree of responsibility in the field of clinical evaluation and support our existing team as follows:
- You will manage projects independently, but in collaboration with our team and the client.
- You will review documents and analyze possible gaps.
- You will prepare the clinical evaluation process and subsequently conduct and document systematic literature searches using various scientific databases.
- You will select and evaluate the literature references and other clinical data based on the intended purpose of the medical device.
- You are responsible for the scientific analysis of the clinical data identified and summary of the results.
- You will prepare a clinical evaluation report according to MEDDEV 2.7/1 Rev. 4 and Regulation (EU) 2017/745 (“MDR”).
- You will coordinate reviews.
- We are an international team working in an international environment. You speak, read and write English and German fluently.
- Further foreign language skills are also welcome.
- We work remotely, and with the best minds in the world.
- You get to work from wherever you like and where you feel you are most efficient.
Would you like to become part of our team? We'd love to meet you!
Regulatory Affairs & Risk Management Expert (f/m/d)
We have been supporting medical device manufacturers around the world providing high-quality services in regulatory affairs since 2018. Our services help manufacturers focus on their actual core business, which is the development of medical devices. As a team, at PRO-LIANCE, we strive to be the best.
- You have relevant professional experience (>5 years) in the field of regulatory affairs/ medical devices.
- You are a scientist at heart (scientific, medical, or engineering university degree, preferably with Ph.D.) and work with attention to detail, when necessary.
- You have a sound knowledge of all the relevant laws, guidelines, and standards (especially MEDDEV 2.7/1 and Regulation (EU) 2017/745).
- You demonstrate sufficient perseverance and tenacity to complete your tasks within the legal framework and project deadlines.
- You have an independent, structured way of working and, at the same time, are also a team player.
- You are reliable and willing to meet expectations, have a high sense of responsibility.
- You work thoroughly and in a goal-oriented manner.
- You are willing to explore and familiarize yourself with new topics.
You will take on tasks, which require a high degree of responsibility in the field of Regulatory Affairs / Risk Management and support our existing team as follows:
- You will plan a strategy for conformity assessment and guide our customers through the conformity assessment process.
- You will assist our customers in meeting the requirements of the MDR (& IVDR).
- You create or update the Technical Documentation (TD) for a medical device (all classes).
- You will support risk management, plan upcoming activities and help define risk acceptance boundaries.
- You know and manage risk management interfaces, especially with regard to usability, biological safety, clinical evaluation, and PMS.
- You communicate with Notified Bodies on an equal footing.
- You keep an eye on the planning process, make sure milestones are being reached, and ensure successful project completion.
- We are an international team working in an international environment. You speak, read and write English and German fluently.
- Further foreign language skills are welcome.
- We work remotely, and with the best minds in the world.
- You get to work from wherever you like and where you feel you are most efficient.
Would you like to become part of our team? We'd love to meet you!
Clinical Evaluation Expert (f/m/d)
We have been supporting medical device manufacturers around the world providing high-quality services in regulatory affairs since 2018. Our services help manufacturers focus on their actual core business, which is the development of medical devices. As a team, at PRO-LIANCE, we strive to be the best.
- You have relevant work experience (>5 years) in the field of clinical evaluation.
- You are a scientist at heart (preferably a medical doctor) and work with attention to detail, when necessary.
- You are familiar with all the relevant laws and standards in the medical device sector (MDR, MDD), with the preparation of clinical evaluations according to MEDDEV 2.7/1 as well as with literature searches and literature databases (Pubmed, Embase etc.).
- You demonstrate sufficient perseverance and tenacity to complete your tasks within the legal framework and project deadlines.
- You have an independent, structured way of working and are a team player at the same time.
- You are reliable, meet expectations and have a high sense of responsibility.
- You work thoroughly and in a goal-oriented manner.
- You are willing to explore and familiarize yourself with new topics constantly
You will take on tasks, which require a high degree of responsibility in the field of Clinical Evaluation and support our existing team as follows:
- You will independently plan and manage projects in collaboration with our team and the client.
- You will perform systematic reviews of clinical evaluations and identify possible gaps. In doing so, you will consider the requirements of the MDR, as well as the Clinical Evaluation Assessment Report Template of MDCG 2020-13.
- You will communicate with the project team and ensure that all identified gaps will be filled.
- You will support our clients by responding to queries from Notified Bodies and participate in meetings with them.
And to keep in the swing of things:
- You will do the clinical evaluation as well as the subsequent systematic literature search, including its documentation, using various scientific databases.
- You will select and evaluate literature references and other clinical data in relation to the intended purpose of the medical device.
- You will be responsible for the scientific analysis of the clinical data and summary of the results.
- You will prepare a clinical evaluation report according to MEDDEV 2.7/1 Rev. 4 and Regulation (EU) 2017/745.
- We are an international team in an international environment. You speak, read and write English and German fluently.
- Further foreign language skills are always welcome.
- We work remotely, and with the best minds in the world.
- You can work from wherever you like and where feel you are most efficient.
Would you like to become part of our team? We'd love to meet you!
Intern / Working Student (f/m/d)
We have been supporting medical device manufacturers around the world providing high-quality services in regulatory affairs since 2018. Our services help manufacturers focus on their actual core business, which is the development of medical devices. As a team, at PRO-LIANCE, we strive to be the best.
- You are a prospective scientist (science, medical or engineering degree) and work with dedication and attention to detail, when necessary.
- You are passionate about clinical evaluation and/or regulatory affairs.
- You demonstrate sufficient stamina and tenacity to take on and master new challenges.
- You have an independent, structured way of working and are a team player at the same time.
- You are willing to explore and familiarize yourself with new topics constantly
For many students, an internship represents their first contact with the industry. We would like to give you an insight into our day-to-day work. It is our aim to help you to make the most of your time with us and gain as much experience as possible.
- As an intern/working student, you will assist your assigned colleague in their daily routines centered around the topic of clinical evaluation.
- You will browse through relevant documents and analyze gaps.
- You actively contribute to the clinical evaluation process (including conducting and documenting systematic literature searches using various scientific databases).
- You will learn how to evaluate literature references.
- You will get a first impression of our clients, communication and working to deadlines.
- We work remotely, and with the best minds in the world.
- You get to work from wherever you like and where you feel you are most efficient.
Would you like to become part of our team? We'd love to meet you!
Proactive application (f/m/d)
You are looking for a new challenge and would like to show us your extraordinary skills but couldn’t find a vacancy? If we have caught your attention, feel free to apply!
Are you looking for a new field of work? We look forward to your application!
OUR VALUES
What can you expect at PRO-LIANCE?
We continuously share our knowledge and train you to further develop your expertise
We work in a modern, remote manner, which is how we get the
best brains from all around the world to work with us.
On account of flat hierarchies we allow you large amount of freedom to make your own decisions.
We work in an international environment, excellent foreign language skills are a prerequisite.
Your personal needs matter to us, which is why we offer you flexible working hours.
Appreciative working methods and a well balanced feedback culture are part of our everyday work.