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- Tasks: Lead clinical regulatory support for active medical devices and ensure compliance.
- Company: Join BSI, a global leader in business standards, helping 80,000 clients worldwide.
- Benefits: Enjoy flexible working, competitive rewards, and opportunities for personal development.
- Why this job: Make a real impact in healthcare while working in a collaborative and diverse environment.
- Qualifications: Degree in medicine, nursing, or related field with strong regulatory knowledge required.
- Other info: Home-based role available across multiple European countries.
The predicted salary is between 43200 - 72000 £ per year.
Great that you’re thinking about a career with BSI!
BSI are unable to provide relocation or visa sponsorship for this vacancy. Due to internal progression we are looking for a Clinical Regulatory Lead with a specialism in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team; This role will be focused around clinical regulatory support to the operational teams and internal clinicians of BSI, and requires an in depth experience and knowledge of regulatory requirements of active medical devices. The successful applicant will support certificate recommendations by providing strong comprehensive working knowledge of the clinical aspects of the regulations, relevant guidance and appropriate standards.
Further duties:
- Provide input and expertise related to competence and certification.
- Monitoring of competence throughout the clinical oversight process by internal auditing.
- Deliver and Support the delivery of audits of medical devices to maintain awareness of BSI's systems, and deal with escalated queries.
- Support process & procedures to be a fully compliant Certification / Notified Body with no systematic non-conformities at audit.
- Provide Medical device expertise leadership and mentoring for existing and new Global Schemes.
- Provide advice and support to Global Heads, Product Specialists and Scheme Managers.
- Support the work of the broader team & training lead in developing and delivering Medical Devices' internal & external training materials, ensuring up to date and accurate knowledge of regulatory changes & amendments.
The successful applicant will have:
- Strong experience and knowledge of the regulatory and compliance requirements of active medical devices.
- A degree or higher degree in medicine, nursing, biomedical sciences, biostatistics or related discipline.
- Broad clinical and technical understanding of client industry products.
- A good understanding of Medical Devices Regulations and related guidance and standards.
- Understanding of clinical evaluation processes, data analysis, clinical study design.
As a team member at BSI, you will enjoy an extensive, competitive total rewards package. This includes annual leave, bank holidays, learning & development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
D&I Policy: BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.
If you require any reasonable accommodations to be made on account of a disability or impairment throughout our recruiting process, please inform your Talent Acquisition Partner.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
Clinical Regulatory Lead employer: The British Standards Institution (BSI)
Contact Detail:
The British Standards Institution (BSI) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Regulatory Lead
✨Tip Number 1
Familiarise yourself with the latest regulations and standards related to active medical devices. This will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the clinical regulatory field, especially those who have experience with active medical devices. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences that showcase your expertise in regulatory compliance and clinical evaluation processes. Real-world scenarios can highlight your problem-solving skills and knowledge.
✨Tip Number 4
Understand BSI's core values and Excellence Behaviours. Be ready to articulate how your personal values align with theirs, particularly in being client-centric, agile, and collaborative, as this will resonate well during the interview.
We think you need these skills to ace Clinical Regulatory Lead
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Clinical Regulatory Lead position. Familiarise yourself with the regulatory landscape for active medical devices to demonstrate your knowledge in your application.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the job description. Emphasise your background in clinical compliance, regulatory requirements, and any specific experience with active medical devices.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific examples from your past experiences that illustrate your expertise in regulatory compliance and your ability to support operational teams effectively.
Highlight Soft Skills: In addition to technical skills, BSI values behaviours like being client-centric, agile, and collaborative. Make sure to include examples in your application that demonstrate these qualities, as they are crucial for success in this role.
How to prepare for a job interview at The British Standards Institution (BSI)
✨Know Your Regulations
Make sure you have a solid understanding of the regulatory requirements for active medical devices. Brush up on the latest Medical Devices Regulations and related guidance, as this knowledge will be crucial during your interview.
✨Demonstrate Clinical Expertise
Be prepared to discuss your clinical background and how it relates to the role. Highlight any experience you have with clinical evaluation processes, data analysis, and clinical study design, as these are key aspects of the position.
✨Showcase Your Leadership Skills
Since the role involves providing expertise and mentoring, think of examples where you've led teams or projects. Be ready to explain how you can support and guide others in the Global Regulatory Compliance team.
✨Emphasise Collaboration
BSI values collaboration, so be prepared to discuss how you've worked effectively in teams. Share experiences that demonstrate your ability to work with diverse groups and how you can contribute to a client-centric and agile environment.
