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- Tasks: Join our team to deliver top-notch regulatory solutions for global clients in the medical device sector.
- Company: We are a leading firm dedicated to ensuring compliance and excellence in regulatory affairs.
- Benefits: Enjoy flexible working options, professional development opportunities, and a vibrant company culture.
- Why this job: Make a real impact in healthcare while collaborating with experts and enhancing your skills.
- Qualifications: Must have an engineering or scientific degree and over 10 years of relevant experience.
- Other info: Opportunity to network at industry events and contribute to innovative projects.
The predicted salary is between 48000 - 72000 £ per year.
To be an integral member and significant contributor to project team(s) in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to regulatory research, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the company’s core values.
Key Responsibilities:
- Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring that internal procedures and client expectations and interests are met.
- Bring considerable experience in IVD/CDx development, validation and approval to client organisations, providing expert strategies and guidance to their development programmes.
- Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to IVDR Annex XIV applications, CTA’s, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
- Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management & conduct of IVD performance studies/clinical investigations worldwide (e.g. IVDR and 21 CFR 812 requirements).
- Manage and keep up-to-date information relating to global regulatory requirements for IVD devices and maintain the company’s web-based clinical trial planning tool.
- Conduct gap analyses on behalf of client companies and prepare associated reports (e.g. technical documentation/design history files).
- Contribute to the preparation of global guidance documents and white papers.
- Contribute to the preparation of other regulatory documents on behalf of client companies (e.g., Performance Evaluation Plans/Reports, Investigator Brochures, etc).
- As required, take advantage of professional networking opportunities to promote the company and its services to appropriate parties.
- Design and deliver formal client presentations, including proposed solutions and client training.
- Prepare and deliver presentation(s) relevant to the company’s regulatory support offerings at industry meetings and conferences.
- Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
- Contribute to ARC company culture initiatives to maintain a positive and engaging workforce.
- Any other duties, within reason and capability, as determined by company management.
Qualifications:
- Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience.
- 5+ years’ experience of working in a medical device/IVD manufacturing or regulatory environment.
- Experience with IVD/CDx design and development, from feasibility to approval.
- Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US).
- Experience of leading global regulatory submissions (e.g. EU/FDA).
- Experience developing and maintaining technical documentation (IVDD/IVDR) or design history file documentation (FDA).
- Experience developing global regulatory strategies for IVD devices.
Senior Specialist- Regulatory Affairs employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist- Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with IVD/CDx devices. Attend industry conferences and seminars to meet potential colleagues and learn about the latest trends and requirements in regulatory compliance.
✨Tip Number 2
Stay updated on global regulatory changes by subscribing to relevant newsletters and joining professional organisations. This knowledge will not only enhance your expertise but also demonstrate your commitment to continuous professional development during interviews.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with regulatory submissions and compliance strategies. Highlight your contributions to successful projects, particularly those involving IVD/CDx development, to showcase your expertise and problem-solving skills.
✨Tip Number 4
Familiarise yourself with StudySmarter's values and culture. During any interactions or interviews, align your responses with our core values to show that you would be a great fit for our team and contribute positively to our company culture.
We think you need these skills to ace Senior Specialist- Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, particularly in IVD/CDx development. Use specific examples that demonstrate your expertise in managing regulatory submissions and compliance solutions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the company's core values. Mention how your experience aligns with the key responsibilities outlined in the job description.
Highlight Relevant Experience: In your application, emphasise your 10+ years of industry experience and any specific projects where you led global regulatory submissions. This will show that you have the necessary background to excel in this role.
Showcase Your Attention to Detail: Since attention to detail is crucial for this position, provide examples in your application that demonstrate your meticulous approach to regulatory documentation and compliance. This could include successful submissions or audits you've managed.
How to prepare for a job interview at HIRANI
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in IVD/CDx development and regulatory submissions. Be prepared to discuss specific projects where you successfully navigated complex regulatory environments, as this will demonstrate your capability to meet client objectives.
✨Prepare for Technical Questions
Expect to be asked detailed questions about regulatory requirements and processes. Brush up on the latest regulations, especially those related to IVDR and 21 CFR 812, so you can confidently answer any technical queries that may arise during the interview.
✨Demonstrate Attention to Detail
Given the nature of the role, it's crucial to exhibit your attention to detail. Bring examples of how you've ensured compliance and accuracy in previous submissions or documentation, as this aligns with the company's core values.
✨Engage with Stakeholders
Be ready to discuss your experience working with internal and external stakeholders. Share examples of how you've effectively communicated and collaborated with different teams to achieve project goals, as this is key to success in the role.
