At a Glance
- Tasks: Support compliance and manage technical documentation for regulated products.
- Company: Established manufacturer in the medical devices sector with a supportive culture.
- Benefits: Competitive salary, hybrid working options, and a hands-on role.
- Other info: Great opportunity for growth and independence in your career.
- Why this job: Make a real impact in regulatory affairs within a dynamic SME environment.
- Qualifications: Experience in medical devices or regulatory affairs and knowledge of ISO13485.
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.
Unfortunately, sponsorship is not available for this position, so applicants must already hold full and unrestricted right to work in the UK.
Regulatory Affairs Specialist in Hertford employer: ProTech Recruitment Ltd
Join a dynamic SME in Hertford as a Regulatory Affairs Specialist, where you will thrive in a supportive and collaborative work culture that values your expertise in regulatory compliance. With flexible hybrid and part-time working options, you will enjoy a balanced work-life while contributing to meaningful projects in the medical device sector. The company prioritises employee growth, offering opportunities for professional development and a chance to make a tangible impact in a hands-on role.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Hertford
✨Tap into Compliance Networks
Join compliance and risk management networks like the Association of Compliance Professionals or local chapters. These communities often share part-time opportunities that might not be advertised widely, plus you'll build connections that could lead to your next gig.
✨Utilise Online Job Boards
Specific job boards like ComplianceCrossing or RiskJobs can help you zero in on part-time roles in compliance. Set up alerts for new listings so you're one of the first to apply—timeliness can really set you apart!
✨Tailor Your Networking Approach
When networking, focus on engaging with compliance professionals on platforms like LinkedIn or attending local industry meetups. Bring up specific laws or recent trends to show off your knowledge and make a memorable impression!
✨Leverage Internships for Part-Time Roles
If you've done an internship in compliance risk, reach out to your past supervisors or colleagues. They often know about part-time openings or can refer you to organisations like ProTech Recruitment Ltd, potentially speeding up your job search.
We think you need these skills to ace Regulatory Affairs Specialist in Hertford
Some tips for your application 🫡
Show Off Your Compliance Knowledge:When applying for a part-time role in compliance-risk, make sure your CV highlights any relevant coursework, certifications, or experience in regulatory frameworks. We want to see your understanding of compliance standards and risk management concepts, so don’t be shy about bragging about those modules or training programmes.
Demonstrate Analytical Skills:Compliance and risk roles are all about dealing with data, so be sure to showcase your analytical skills in your application. Include specific examples of how you've used analytical tools or methods to identify risk or ensure compliance in previous roles or projects. Trust us, this will make your application stand out!
Emphasise Your Availability:Since this is a part-time role, it's really important to communicate your availability clearly. In your cover letter, let us know your preferred hours and if you're flexible. This helps us see how you can fit into our team and the schedules we need to cover.
Tailor Your Cover Letter to Show Interest:In your cover letter, show us why you want to work in compliance-risk specifically for ProTech Recruitment Ltd. Tell us about your passion for helping organisations maintain compliance and how you can contribute to our goals. Personalising this will definitely help make your application more memorable, so take that extra step!
How to prepare for a job interview at ProTech Recruitment Ltd
✨Understand Regulatory Frameworks
For a role in compliance-risk, it's crucial to have a solid grasp of the relevant regulations and frameworks, like GDPR or anti-money laundering laws. Brush up on these areas, and be ready to discuss how your knowledge applies to scenarios you might face at ProTech Recruitment Ltd.
✨Prepare Case Studies
Since we’re looking at a part-time gig, interviewers may want to see how you approach real-world problems. Prepare some case studies related to risk assessment or compliance frameworks that showcase your analytical skills and decision-making process. This will help you stand out as someone who's ready to jump into the action.
✨Show Off Your Detail Orientation
In compliance, attention to detail is everything. Bring examples from your past experiences where your diligence made a difference, whether that’s spotting a regulatory oversight or ensuring a process was followed to the letter. We want to highlight how this skill can benefit ProTech Recruitment Ltd.
✨Connect Your Part-Time Availability
Make it clear how your part-time availability aligns with the needs of ProTech Recruitment Ltd. Talk about how your time management skills will help you keep on top of tasks and responsibilities, ensuring you can maximise your impact even with part-time hours.
