Regulatory Affairs Manager | Medical Devices | 7 months
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Antwerpen Belgium.
They are pioneers in medical devices, continually focused on elevating the standard of care-working to expand patient access, improve outcomes, reduce health system costs and drive value. Creating smart, people-centered healthcare to help the patients they serve recover faster and live longer and more vibrantly.
- Coordinating product regulatory GAP assessments against MDR 2017/745 and relevant harmonized standards
- Create and review Technical Files and design dossiers for submission in EMEA (might involve interacting with external development parties)
- Coordination of responses to request from notified bodies and regulatory authorities in order to expedite approval of regulatory submissions
- Evaluate regulatory impact of product changes
- 10 years' of experience with Regulatory strategies and EU conformity assessments for molecular In Vitro Diagnostics and Medical Devices
- Knowledge about design controls, software development process, computer system validation and cybersecurity
- Familiar with development of PCR test or next gen sequencing, validation and performance characteristics of such test, clinical validation protocols and reports
- Proficient use of digital technology
- Working language will be Dutch and English
- French is a plus
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
The Company
This company is using their scale and experience to re imagine the way healthcare is delivered and help people live longer, healthier lives. In a radically changing environment they are making connections across science and technology to combine our own expertise in surgery, orthopedics, vision and solutions with the big ideas of others to design and deliver physician and patient-centric solutions and products.They are pioneers in medical devices, continually focused on elevating the standard of care-working to expand patient access, improve outcomes, reduce health system costs and drive value. Creating smart, people-centered healthcare to help the patients they serve recover faster and live longer and more vibrantly.
Role Description
You will support the Regulatory Diagnostics team for registration of Software as Medical Device and Companion Diagnostics in the EMEA region. Preparing and reviewing regulatory strategies and plans for Medical Devices and In Vitro Diagnostics.Responsibilities
- Perform Regulatory Assessments for product qualification as Medical Device- Coordinating product regulatory GAP assessments against MDR 2017/745 and relevant harmonized standards
- Create and review Technical Files and design dossiers for submission in EMEA (might involve interacting with external development parties)
- Coordination of responses to request from notified bodies and regulatory authorities in order to expedite approval of regulatory submissions
- Evaluate regulatory impact of product changes
Requirements
- Minimal Bachelors' degree in Biochemistry, Microbiology, Pharmacy or other Life-Sciene or health-related field.- 10 years' of experience with Regulatory strategies and EU conformity assessments for molecular In Vitro Diagnostics and Medical Devices
- Knowledge about design controls, software development process, computer system validation and cybersecurity
- Familiar with development of PCR test or next gen sequencing, validation and performance characteristics of such test, clinical validation protocols and reports
- Proficient use of digital technology
- Working language will be Dutch and English
- French is a plus
Other information
The company is looking for a collaborative team-player with a dynamic personality. Excellent skills verbal and written and a detail oriented regulatory leader.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
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