At a Glance
- Tasks: Plan and coordinate regulatory activities for innovative medical devices.
- Company: Join Medicareplus International, a leader in advanced wound care and infection prevention.
- Benefits: Competitive salary, 25 days holiday, mobile phone, laptop, and professional development opportunities.
- Other info: Collaborative culture with excellent career growth and lifestyle benefits.
- Why this job: Make a real difference in patient care while working with a supportive team of experts.
- Qualifications: 5+ years in medical device regulatory roles with strong knowledge of EU MDR and ISO 13485.
The predicted salary is between 60000 - 75000 £ per year.
At Medicareplus International, we pride ourselves on being a leading force in advanced wound care and infection prevention. Our mission focuses on creating innovative products that enhance patient care and support healthcare professionals. Join us in our commitment to excellence and become part of a culture that values collaboration and innovation.
We are now looking for a Senior RA Specialist to plan, prepare, and coordinate regulatory activities to ensure that the company's medical devices comply with applicable global regulations, standards, and internal policies. The Senior RA Specialist will support product registrations, the compilation and upkeep of technical documentation, clinical evaluations, labelling compliance, and interactions with regulatory authorities and Notified Bodies.
Roles and Responsibilities- Technical Documentation
- Develop and maintain Technical Documentation in line with ISO 13485, the Medical Device Regulation 2017/745 (EU MDR) and other applicable regulatory requirements.
- Support the creation and review of labelling and marketing materials to ensure compliance with relevant regulations.
- Participate in design and development projects to provide regulatory input on classification, intended use, and regulatory pathways.
- Develop and maintain Clinical Evaluation Plans and reports in accordance with EU MDR.
- Coordinate the collection and analysis of clinical data, literature reviews, and post-market clinical follow-up activities.
- Support the preparation of Periodic Safety Update Reports and Summary of Safety and Clinical Performance where applicable.
- Collaborate with Clinical, Quality and Marketing teams to monitor and report on device performance and safety.
- Regulatory Intelligence and Compliance
- Monitor changes to applicable legislation, standards, and guidance, assess and communicate impact in line with the procedures.
- Support implementation of regulatory updates into procedures, processes, and product documentation.
- Quality System Support
- Participate in internal and external audits, including Notified Body and Competent Authority inspections.
- Support vigilance and post-market surveillance activities, including adverse event reporting, field safety corrective actions, and periodic safety update reports.
- Assist in maintaining and improving the Quality Management System where it intersects with regulatory requirements.
- Cross-Functional Collaboration
- Liaise with Medicareplus SMEs, Quality Assurance, Clinical, Marketing and Operations teams to ensure alignment of regulatory strategies with business objectives.
- Provide regulatory and clinical support during product launches, changes, or discontinuations.
- 5+ years in the medical device industry in a similar Regulatory role.
- Strong knowledge of EU MDR 2017/745, ISO 13485, and other relevant international regulatory frameworks and standards.
- Proven ability to compile, maintain, and submit Technical Documentation, product registrations, and regulatory submissions to authorities and Notified Bodies.
- Experienced in clinical evaluation activities, including Clinical Evaluation Plans/Reports, literature reviews, and post-market clinical follow-up.
- Solid understanding of labelling compliance, product classification, intended use determination, and regulatory pathways during product development.
- Skilled in post-market surveillance and vigilance activities, including adverse event reporting, PSURs, and field safety corrective actions.
- Strong, pragmatic collaborator across Quality, Clinical, Marketing, R&D, and Operations, supporting product launches and ongoing compliance.
- Competitive salary and bonus
- 25 days holiday + public/bank holiday
- Mobile phone and laptop
- Learning & Development - We encourage professional development and progression for all our team.
- Lifestyle Benefits: Our Employee Assistance Programme offers a range of services including financial, wellbeing and counselling via Wisdom Wellbeing; a range of discounts are offered via Bright Exchange.
- Online GP Services - Access to an online GP service via Livi.
- Team building events.
Based in our Alperton office, this role is your chance to join a collaborative, supportive team of experts. If you want to work together to make a real difference, apply now!
Senior Regulatory Affairs Sepcialist Quality & Regulatory London employer: Medicareplus International Ltd
At Medicareplus International, we are dedicated to fostering a collaborative and innovative work environment that empowers our employees to excel in their roles. As a Senior Regulatory Affairs Specialist in our Alperton office, you will benefit from competitive salaries, generous holiday allowances, and extensive professional development opportunities, all while contributing to meaningful advancements in patient care. Join us to be part of a supportive team that values your growth and well-being, ensuring you have the resources to thrive both personally and professionally.
Contact Details:
Medicareplus International Ltd Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Sepcialist Quality & Regulatory London
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Medicareplus International Ltd looking for candidates who are engaged and informed.
We think you need these skills to ace Senior Regulatory Affairs Sepcialist Quality & Regulatory London
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Medicareplus International Ltd. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Medicareplus International Ltd
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Medicareplus International Ltd’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
