Regulatory Affairs Specialist
3 days ago
Yolk Recruitment is partnering with a pioneering medical device business to find a talented Regulatory Affairs Specialist to join their team.
This is an exciting opportunity to be part of a high-growth, innovative business in a rewarding field. As a Regulatory Affairs Specialist, you will play a key role in providing guidance on regulatory affairs and supporting the development of new products.
Key Responsibilities:
- Lead regulatory affairs activities and serve as the primary point of contact for compliance enquiries.
- Work with colleagues across the business to ensure compliance with regulatory requirements.
- Collaborate with NPD teams to review and approve documents, and participate 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 requirements and standards.
- Excellent communication and collaboration skills.
- Ability to work in a fast-paced environment and prioritize tasks effectively.
This is a fantastic opportunity to join a dynamic team and contribute to the success of a pioneering medical device business.
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