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We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to join our team, with at least 2 years’ experience in Medical Device Regulatory Affairs, Post Market Surveillance, Quality Assurance or Design Control or related function. In this role, you will be responsible for ensuring that our products comply with all regulatory requirements and standards. You will play a crucial part in the development and maintenance of regulatory submissions, working closely with various departments to facilitate compliance and quality assurance throughout the product lifecycle.
Responsibilities
* Prepare and submit regulatory documents to relevant authorities in accordance with established guidelines.
* Review product labels, promotional materials, and technical documentation for compliance with regulatory standards.
* Liaise with internal teams, including Quality Assurance and Research & Development, to ensure that all aspects of product development meet regulatory requirements.
* Monitor changes in regulations and assess their impact on existing products and processes.
* Conduct audits of documentation and processes to ensure compliance with internal policies and external regulations.
* Provide training and guidance to staff on regulatory requirements and best practices.
* Assist in the preparation for regulatory inspections and audits by maintaining accurate records and documentation.
Skills
* Strong understanding of regulatory frameworks relevant to the industry, including quality assurance principles.
* Excellent attention to detail with strong analytical skills for reviewing complex documents.
* Ability to communicate effectively both verbally and in writing, presenting information clearly to diverse audiences.
* Proficient in using regulatory databases and document management systems.
* Strong organisational skills with the ability to manage multiple projects simultaneously while meeting deadlines.
* A proactive approach to problem-solving, with the ability to work independently as well as part of a team.
If you are passionate about ensuring product compliance and have a keen eye for detail, we invite you to apply for this exciting opportunity as a Regulatory Affairs Specialist.
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