Regulatory Compliance Expert
5 days ago
About the Role:
This is an exciting opportunity for a Regulatory Compliance Expert to join our team in Cambridge. As a key member of the product development team, you will play a critical role in ensuring that our products meet regulatory requirements and customer expectations.
Responsibilities:
- Develop and maintain knowledge of regulatory requirements and industry standards
- Lead design control and risk management activities for combination product development programs
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards
Requirements:
- BSc in an appropriate science & engineering discipline
- Previous experience in pharmaceutical combination product and/or device industries
- History of working in accordance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation
- Experience in design controls and risk management for combination products
- Familiarity with Human Factors Engineering - Usability Engineering
Payscale Information:
$100,000 - $115,000 per annum.
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