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- Tasks: Join our team to ensure global compliance solutions for client companies.
- Company: We are a leading firm in regulatory affairs, dedicated to excellence and innovation.
- Benefits: Enjoy flexible working options and opportunities for professional development.
- Why this job: Make a real impact in the medical device industry while growing your career.
- Qualifications: Engineering or Scientific honours degree with 5+ years in medical device regulation.
- Other info: Contribute to a positive company culture and engage in networking opportunities.
The predicted salary is between 36000 - 60000 £ 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 and quality assurance expertise to client companies, ensuring client expectations and interests are met.
Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to 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 worldwide.
Manage and keep up to date information relating to regulatory requirements for IVD performance studies and maintain the company’s web-based clinical trial planning tool.
Conduct gap analyses on behalf of client companies and prepare associated reports
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.
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.
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
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Regulatory Affairs Specialist employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to IVD devices in key global markets. This knowledge will not only help you understand the requirements better but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs community, especially those who have experience with IVD/CDx devices. Attend industry conferences or webinars to make connections that could lead to valuable insights and potential job opportunities.
✨Tip Number 3
Showcase your experience with global regulatory submissions by discussing specific projects you've worked on. Be prepared to explain your role in these submissions and how you contributed to their success during interviews.
✨Tip Number 4
Highlight your attention to detail and work ethic in conversations with potential employers. Share examples of how these traits have positively impacted your previous projects, particularly in regulatory research and documentation.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in the medical device or IVD sector. Emphasise your achievements in leading global regulatory submissions and developing technical documentation.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the company's core values and how your work ethic aligns with them. Mention specific examples of how you've exceeded client expectations in previous roles.
Highlight Relevant Skills: In your application, clearly outline your skills related to regulatory research, stakeholder management, and gap analysis. Use keywords from the job description to ensure your application stands out.
Showcase Continuous Learning: Mention any continuing professional development activities you've undertaken to stay updated on regulatory standards. This demonstrates your commitment to the field and aligns with the company's emphasis on professional growth.
How to prepare for a job interview at HIRANI
✨Know Your Regulations
Familiarise yourself with the key regulations related to IVD and CDx devices, especially those in the EU and US markets. Be prepared to discuss how these regulations impact the development and approval processes during your interview.
✨Showcase Your Experience
Highlight your relevant experience in regulatory affairs, particularly any specific projects where you led global submissions or developed regulatory strategies. Use concrete examples to demonstrate your expertise and how it aligns with the company's needs.
✨Emphasise Attention to Detail
Given the nature of regulatory work, attention to detail is crucial. Prepare to discuss instances where your meticulous approach has positively impacted project outcomes or compliance. This will show that you understand the importance of precision in this role.
✨Engage with Stakeholders
Be ready to talk about your experience working with internal and external stakeholders. Discuss how you’ve successfully managed relationships and communicated complex regulatory information to ensure client satisfaction and project success.
