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Job Title:
Clinical Regulatory Lead - ACTIVE DEVICES
Reports to:
Associate Head of Clinical Compliance
Location:
Home based in UK, Spain, Germany, Ireland, Netherlands, Italy, France
BSI cannot provide relocation or visa sponsorship for this vacancy.
We are looking for a Clinical Regulatory Lead with expertise in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team. This role focuses on clinical regulatory support to operational teams and internal clinicians, requiring extensive knowledge of regulatory requirements for active medical devices. The successful candidate will support certification recommendations through a strong understanding of clinical aspects of regulations, guidance, and standards.
Responsibilities include:
* Providing expertise related to competence and certification
* Monitoring competence through internal audits during the clinical oversight process
* Conducting and supporting audits of medical devices to ensure compliance and address escalated queries
* Supporting processes to maintain full compliance as a Certification / Notified Body
* Leading and mentoring on medical device expertise within global schemes
* Advising and supporting Global Heads, Product Specialists, and Scheme Managers
* Developing and delivering training on medical devices, keeping up with regulatory changes
Candidate requirements:
* Strong experience with regulatory and compliance requirements of active medical devices
* Degree or higher in medicine, nursing, biomedical sciences, biostatistics, or related field
* Broad clinical and technical understanding of industry products
* Knowledge of Medical Devices Regulations, guidance, and standards
* Understanding of clinical evaluation, data analysis, and study design
Do you believe the world deserves excellence? At BSI, we help 80,000 clients worldwide improve their business, from medical devices to space exploration. We offer a comprehensive rewards package, including leave, holidays, development opportunities, and flexible benefits.
Our core behaviors are Client-centric, Agile, and Collaborative, ensuring a great workplace and business success.
Diversity & Inclusion
We are committed to reflecting the diversity of our clients and communities, fostering a sense of belonging, and providing growth opportunities for all employees. If you need accommodations during the recruitment process, please inform your Talent Acquisition Partner.
We conduct face-to-face interviews where appropriate; virtual options are available upon request.
Additional details:
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Healthcare Provider, Professional Services
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