Description
Regulatory Affairs Consultant Medical Devices - ContractPlease contact Steven Ruddy from Real Pharma - Medical Devices on
My client is looking for a Senior Regulatory Affairs Specialist to act as the SME in external regulators for the activities necessary for the establishment and maintenance of the regulatory requirements for the company's NPD of a medical device.
Experience required;
- Experience of working directly with regulators and experience of active medical devices is a strong requirement.
- Evidence of training in medical device regulatory affairs is required.
- Working knowledge and experience of the medical device manufacturing industry with a minimum of 4 years direct regulatory experience is a requirement.
- A Bachelor of Science or Engineering degree from an accredited school in an engineering/technical discipline is required.
Responsibilities;
- Develop and maintain Essential Requirements/Principles checklists.
- Maintain the compliance library and the list of applied standards. Review the impact of changes to standards and help manage any required conformance and engineering change activities.
- Write and maintain (update and review annually) risk assessments and support the maintenance of the device risk management files and overall risk management activity across the product lifecycle (e.g. to ISO14971).
- Write and maintain product submissions to relevant regulatory agencies.
- Manage post market surveillance activities.
Regulatory Affairs Consultant Medical Devices £55 - £60ph Immediate Start
Please contact Steven Ruddy from Real Pharma - Medical Devices on
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