Regulatory Affairs/CMC Medical Device Professional

Proclinical is currently recruiting for Regulatory Affairs/ CMC Medical Device Professional with a biotechnology company in Cambridge, MA. The candidate will provide regulatory support including single entity and co-packaged products. Specifically, regulatory affairs (CMC/medical device) professional with combination product experience. A successful candidate will have experience in preparing submissions (NDA/BLA or MAA) with combination product/medical device contents and oversight of development team working on the combination product/medical device aspects (design controls).

Job Responsibilities:

• Investigate and write investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology
• Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability

Skills and Requirements:

• Regulatory Affairs, Combination Products and/or Medical Devices, some CMC experience (for drugs and/or biologics) preferred
• Drug delivery systems -preferably pre-filled syringes and/or co-packaged delivery devices.
• Ideally experience with coordinating or contributing to container closure & device global filing CTD content within M3 (US BLA & EU MAA), plus regulatory oversight experience with Design Controls including design verification & validation, human factors/usability studies, control strategies, and working with external suppliers
• Experienced in technical/regulatory writing
• Good communication skills and experience working cross-functionally and globally
• Experience working with external suppliers, particularly for device components and container closure systems
• Quick learner and able to navigate electronic systems to find information and apply to the given program

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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