At a Glance
- Tasks: Support compliance and manage technical documentation for regulated products.
- Company: Established manufacturer in the medical device sector with a hands-on approach.
- Benefits: Competitive salary, hybrid working options, and a supportive team environment.
- Other info: Ideal for detail-oriented individuals seeking to thrive in an SME setting.
- Why this job: Make a real difference in regulatory affairs while growing your expertise.
- Qualifications: Experience in medical devices and knowledge of relevant regulations required.
The predicted salary is between 40000 - 40000 £ per year.
An established manufacturer of regulated products is seeking a Regulatory Affairs Coordinator to support the ongoing maintenance of compliance and technical documentation across an established portfolio of products. This is a hands-on role suited to someone who enjoys practical regulatory work within an SME environment and can efficiently manage documentation and compliance activities without unnecessary complexity.
Responsibilities:
- Maintain UK and EU product registrations.
- Review and maintain Technical Files and supporting documentation.
- Prepare and maintain PMS, PSUR and Clinical Evaluation documentation.
- Review and update IFUs and product labelling.
- Monitor regulatory updates and ensure ongoing compliance.
- Prepare technical justifications, gap analyses and briefing notes.
- Support customer regulatory queries and external audits.
- Maintain electronic and physical document control systems.
Requirements:
- Previous experience within medical devices, regulatory affairs or quality assurance.
- Knowledge of ISO13485 and medical device regulations including MDR, MDD and UKCA.
- Experience with Technical Files and technical documentation.
- Strong organisational skills and attention to detail.
- Comfortable working independently within an SME environment.
Regulatory Affairs Specialist employer: ProTech Recruitment Ltd
Join a dynamic and supportive team as a Regulatory Affairs Specialist in Hertford, where your expertise will directly contribute to the compliance and success of innovative regulated products. Our SME environment fosters a collaborative work culture that values practical regulatory work, offering you the chance to grow your skills while enjoying the flexibility of hybrid and part-time working options. With a commitment to employee development and a focus on maintaining high standards, we provide a rewarding workplace for those looking to make a meaningful impact in the medical device sector.
