Clinical Regulatory Lead

BSI; Sevilla; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

BSI is looking for a Clinical Regulatory Lead specializing in active medical devices. This mid-senior level role involves providing clinical regulatory support, ensuring compliance, conducting audits, and developing training. The successful candidate will join a global team, contributing to BSI's mission of excellence in regulatory compliance.

Servicios

Competitive benefits package

Supportive work environment

Formación

• Experience with regulatory and compliance requirements for active medical devices.
• Understanding of Medical Devices Regulations and guidance.
• Broad clinical and technical understanding of industry products.

Responsabilidades

• Provide expertise related to competence and certification.
• Conduct audits of medical devices and maintain compliance.
• Develop and deliver training on Medical Devices regulations.

Conocimientos

Regulatory knowledge

Clinical evaluation

Data analysis

Clinical study design

Educación

Degree or higher in medicine, nursing, biomedical sciences, or biostatistics

Descripción del empleo

Join us to apply for the Clinical Regulatory Lead - ACTIVE DEVICES role at BSI.

Great that you're considering a career with BSI!

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.

Role Overview:

We are seeking a Clinical Regulatory Lead with expertise in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team. This role involves clinical regulatory support to operational teams and clinicians within BSI, requiring in-depth knowledge of regulatory requirements for active medical devices. The successful candidate will support certification recommendations by providing comprehensive clinical knowledge of regulations, guidance, and standards.

Key Responsibilities:

• Provide expertise related to competence and certification.
• Monitor competence throughout clinical oversight via internal audits.
• Conduct audits of medical devices, maintain awareness of BSI’s systems, and handle escalated queries.
• Support processes to ensure full compliance as a Certification / Notified Body with no systematic non-conformities.
• Lead and mentor on Medical device expertise for Global Schemes.
• Advise Global Heads, Product Specialists, and Scheme Managers.
• Develop and deliver training on Medical Devices, ensuring up-to-date knowledge of regulatory changes.

Candidate Profile:

• Strong experience and knowledge of regulatory and compliance requirements for active medical devices.
• Degree or higher in medicine, nursing, biomedical sciences, biostatistics, or related fields.
• Broad clinical and technical understanding of industry products.
• Good understanding of Medical Devices Regulations, guidance, and standards.
• Knowledge of clinical evaluation, data analysis, and clinical study design.

About BSI:

BSI helps 80,000 clients worldwide improve their businesses across various sectors, including medical devices and space exploration. We foster a culture of excellence, innovation, and sustainability, offering a competitive benefits package and a supportive work environment.

Our Values and Policies:

We prioritize diversity and inclusion, aiming to create a sense of belonging for all employees. We accommodate reasonable adjustments during our recruitment process for candidates with disabilities. Interviews may be conducted face-to-face or virtually, depending on comfort and circumstances.

Additional Details:

• Seniority Level: Mid-Senior level
• Employment Type: Full-time
• Job Functions: Healthcare Provider
• Industries: Professional Services

Referrals can double your chances of an interview. Set job alerts for similar roles.

Location and Recent Postings:

Madrid, Spain and other locations with recent postings in the past weeks.