» Project Regulatory Affairs Specialist

Our client is looking for a Project Regulatory Affairs Specialist to take a leading role in the regulatory compliance aspects of multi-disciplinary device development projects in the field of drug delivery products, in-vitro diagnostics, and surgical products.

Your specific responsibilities will include:
· Identification of product classification and approval authority
· Definition of regulatory strategy for product or system developments
· Definition of specific quality management processes, within the existing ISO 9001 system.
· Identification of compliance tasks in the overall development plan
· Preparation of project quality, risk management, verification and validation plans
· Identification and preparation of design verification protocols
· Preparation of verification and validation reports
· Identifying process validation requirements


Experience Required:
To meet the requirements of this role you should have a high level of regulatory experience, preferably gained in a R&D environment. Exposure to the healthcare industry is vital, with experience at a pharmaceutical or medical device company being a strong advantage. Your degree may be in life-sciences or engineering.

Your specific expertise will include some of the following:
· Regulatory/Quality planning
· Risk analysis techniques (eg FTA and/or FMEA)
· Software V&V planning
· SOP preparation
· V&V Protocol preparation
· Design control
· Change control
· Standards analysis

Experience in clinical trials design and planning is desirable, as is the knowledge of the EMEA and FDA approvals process for combination products.

Cambridge, Cambridgeshire | Salary £neg.
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