Proclinical is seeking a Medical Device Quality Consultant with a focus on Design Controls. This role is integral to the development of a Biologics License Application (BLA). The successful candidate will manage Design Output/Verification remediation activities, ensure design verification testings are accurate and exhaustive, and actively support the establishment and review of the Product Risk Management documentation. This role also involves active participation in the review of Design Control section for BLA submission and continuous improvement of design control processes.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Act as the Combination Product Project Manager to manage Design Output / Verification remediation activities
- Ensure design verification testings are in line with current FDA and EMA requirements and regulations
- Act as a liaison between the Development Team and Design Control Team
- Provide active support to the establishment and review of the Product Risk Management documentation
- Participate in the review of Design Control section for BLA submission
- Advise and involve in the continuous improvement of design control process
Key Skills and Requirements:
- Ability to work independently and in a global team environment
- Strong collaborative spirit and organizational skills
- Extensive Design Control experience and familiarity with both US FDA and EU EMA regulations
- Knowledge of US Medical Device Regulation according 21 CFR 820.30 and ISO 13485
- Experience in Combination Product (biologic) BLA submission and approval
- Risk management skills and knowledge of ISO 14971:2019
- Transversal project management skills
- Excellent verbal and written communication skills
- Experience in combination product (biologic)/medical device development
- Knowledge of Pharmaceutical development ICH Q8 & QbD skills is a plus
- Proficiency in English and French
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
If you are having difficulty in applying or if you have any questions, please contact Will Hitchcock at w.hitchcock@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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