RA Manager for Medical Device or Combination Products DevelopmentPostuler
Do you like challenges?
Do you seek for reaching ambitious goals?
Do you love managing complex, high-tech product development projects in an international and multi-cultural setting?
Do you naturally motivate teams you are part of to achieve inspiring goals through teamwork and dedication?
Then you may be the RA Manager we are looking for.
Draw your own challenges
CSDmed is a fast growing company in the area of consulting for medical devices and combination products located in the Principality of Monaco. Join us on our exciting journey and help us develop innovative solutions to improve the life of thousands of patients across the world.
You will be part of CSDmed. You will settle on the French Riviera, you will have a contract in Monaco, and follow Monaco healthcare and pension plans. You will work for and with clients all across the globe. Remote office is appreciated.
Your Key Responsibilities may include
- Define the regulatory strategy according to the normative context and the client's projects in development.
- Constitute and write CE marking technical files or modification files.
- Participate in risk management, usability engineering, biological evaluation and clinical evaluation activities.
- Coordinate the registration of products in the different countries.
- Participate in the development of the CMC regulatory strategy.
- Develop and write all or part of the regulatory files: IMPd, NDA, IND, MA module 3.
- Prepare the registration files.
- Track renewal and variation requests.
- Respond to questions from health authorities.
Your Experience Range allows you to provide support in fields like
- Technical files construction and submission
- Design Controls
- Risk management activities
You may be familiar with various standards or regulations like
- ISO 13485 and 21CFR820
- 21CFR210 and 21CFR211 would be a plus
- MDR 2017/745 and IVDR 2017/746
- ISO 14971
- ISO 14155
CSDmed offers the opportunity to lead various types of projects: concept projects, new product development, and product sustaining.
A proven track record in technical product development
In order for you to be a success in this position, it is essential for you to have a documented experience from companies within the area of medical devices or combination products. Furthermore, we expect you to hold a relevant degree in combination with at least 3 years of experience from the above-mentioned areas.
Required Skills And Qualifications
- Master Degree in Industrial Microbiology and Biotechnologies, or in Biomedical Engineering
- A minimum of 3 years of experience in medical device industry
- Experience from working with cross-professional teams across multiple sites
- Fluency in English (spoken/written); mastering French will be an advantage
- Experience from medical device / combination products development and medical device standards will be an advantage.
Team player by heart
- You are results driven, and know how to set goals – and how to reach them with your team
- You think and act holistic and like to take responsibility
- You are a skilled in creating and maintaining good relations to all parts of the organization
- You have a natural authority in you management style
- You have a general technical insight and curiosity to support a multi-disciplinary work environment
- You are a team player by heart with a natural ability to motivate
- You are pragmatic and strive for efficiency in all that you do
- You are able to travel to meet and work with the customers
Why you should apply
We can offer you an informal and open working environment that does not lock you into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference.
At CSDmed, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.
If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.