Regulatory Affairs Specialist

CELOX Medical; Crewe; Hybrid; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a detail-oriented Regulatory Affairs Specialist to ensure compliance with regulatory standards in the medical device sector. This role involves preparing regulatory submissions, liaising with internal teams, and monitoring regulatory changes. If you have a strong understanding of regulatory frameworks and a passion for quality assurance, this is an exciting opportunity to contribute to product compliance and quality throughout the product lifecycle. Join a dynamic team committed to excellence and innovation in the medical field.

Qualifications

• At least 2 years’ experience in Medical Device Regulatory Affairs.
• Strong understanding of regulatory frameworks and quality assurance.

Responsibilities

• Prepare and submit regulatory documents to authorities.
• Liaise with internal teams to ensure compliance with regulations.
• Conduct audits and provide training on regulatory requirements.

Skills

Regulatory Frameworks

Quality Assurance Principles

Analytical Skills

Communication Skills

Document Management Systems

Organisational Skills

Tools

Regulatory Databases

Job description

Job Overview

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.

Please not there is a requirement to be in the office 3 days per week in Crewe, Cheshire.

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.

Please note you must have the right to work in the UK as we do not offer any Visa sponsorship.