Regulatory Affairs Professional

6 days ago

Cardiff, Cardiff, United Kingdom Yolk Recruitment Full time
Regulatory Affairs Professional

Yolk Recruitment is partnering with a pioneering medical device business to fill a new opportunity for a Regulatory Affairs Specialist. This role offers the chance to be part of a high-growth, high-innovation business in a rewarding field, providing guidance on a wide range of regulatory affairs.

Key Responsibilities:

* Lead regulatory affairs activities and serve as the primary point of contact for compliance enquiries.
* Work with colleagues throughout the business: R&D, Legal, Sales and Operation.
* Collaborate with NPD teams, reviewing and approving documents, and participating in design and stage gate reviews.
* Monitor new standards and ensure NPD meets recognized consensus standards.
* Participate in CAPA teams to resolve issues and ensure continuous compliance.
* Prepare and maintain technical files to meet regulatory requirements.
* Develop and implement regulatory strategies for NPD and existing products.

Requirements:

* Experience in Regulatory Affairs in the medical device industry.
* Strong knowledge of regulatory standards and guidelines.
* Excellent communication and collaboration skills.
* Ability to work in a fast-paced environment and prioritize tasks effectively.

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

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