Combination Product Documentation Specialist

Proclinical are recruiting for a Combination Product Documentation Specialist to join a biotech. This role is on a contract basis and is located in Paris with hybrid working available.

Responsibilities:

• You will develop the design verification plan and matrix.
• Adhere to the protocols for the study and gather data linked to the design verification.
• Responsible for authoring design control documentation.
• Accountable for preparing design evaluation steps.
• Handle active contributions to the evaluation of design control selection for BLA proposal.
• Other duties may be assigned.

Key Skills and Requirements:

• Knowledge of design control, which involves US Medical Device Regulation according 21 CFR 820.30; ISO 13485 etc.
• Familiarity within Combination Product BLA proposal and approval.
• Expertise on risk management, i.e., ISO 14971; Risk management file; etc.
• Abilities in Combination Product development and transversal project management.
• Pharmaceutical development ICH Q* & QBD capabilities would be ideal.
• Demonstrable experience within Combination Product/medical device.
• Fluency in the English language with knowledge in French would be ideal.

If you are having difficulty in applying or if you have any questions, please contact Connie Prince at c.prince@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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