Regulatory Affairs Specialist
1 month ago
Regulatory Affairs Consultant
- Standardised pension
- Free parking
- Life Insurance
- Sick pay package
- Hybrid working model
We are exclusively partnered with an expanding medical device business who are looking to acquire a QARA Consultant. This role will provide you with the opportunity to work with a wide variety of medical device businesses ranging from family businesses to multinationals.
This role would be well suited to an experienced candidate with experience working in the medical device sector within the field of regulatory affairs completing tasks such as clinical evaluations and risk management.
Key responsibilities include:
- Ensuring compliance with industry regulations and standards in line with client requirements.
- Developing and implementing quality assurance processes.
- Conducting audits (stage 1 and 2) to assess adherence to quality standards.
- Providing guidance on regulatory requirements.
- Collaborating with teams to maintain product quality and safety.
- Navigating regulatory submissions for products.
- Staying updated on evolving regulatory requirements.
- Assisting in resolving compliance issues and implementing corrective actions.
A degree in medical engineering or a life sciences subject will be beneficial, alongside a lead auditor qualification.
Experience working in the medical device sector is essential.
Proven experience in managing clinical evaluations, technical file creation, and risk management.
Working in a regulatory affairs and quality assurance capacity will be required for this position.
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