Regulatory Affairs Specialist

CELOX Medical; Crewe; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading medical equipment manufacturing company is seeking a Regulatory Affairs Specialist to ensure product compliance with regulatory standards. This role involves preparing regulatory submissions, collaborating with internal teams, and monitoring industry regulations, requiring at least 2 years' experience in regulatory affairs.

Qualifications

• At least 2 years' experience in Medical Device Regulatory Affairs.
• Strong attention to detail and organizational skills.
• Ability to manage multiple projects while meeting deadlines.

Responsibilities

• Prepare and submit regulatory documents to authorities.
• Review product labels for compliance.
• Monitor changes in regulations affecting products.

Skills

Regulatory frameworks understanding

Analytical skills

Effective communication

Project management

Problem-solving

Tools

Regulatory databases

Document management systems

Job description

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This range is provided by CELOX Medical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from CELOX Medical

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other and Manufacturing

• Industries

  Medical Equipment Manufacturing

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