Clinical Regulatory Lead

BSI; Valladolid; A distancia; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

A leading company in professional services is seeking a Clinical Regulatory Lead focused on active medical devices. The role involves providing regulatory support and ensuring compliance with clinical standards while offering competitive rewards and development opportunities. This mid-senior level position allows for flexible working arrangements across several countries.

Servicios

Competitive rewards

Development opportunities

Flexible benefits

Formación

• Extensive knowledge of regulatory and compliance requirements for active medical devices.
• Broad clinical and technical understanding of industry products.
• Strong understanding of Medical Devices Regulations and standards.

Responsabilidades

• Provide expertise related to competence and certification.
• Conduct and support audits of medical devices.
• Lead and mentor on medical device expertise.

Conocimientos

Knowledge of regulatory requirements

Clinical evaluation

Data analysis

Study design

Educación

Degree in medicine, nursing, biomedical sciences, biostatistics, or related fields

Descripción del empleo

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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.

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 providing clinical regulatory support to operational teams and internal clinicians, requiring in-depth knowledge of regulatory requirements for active medical devices. The successful candidate will support certification processes by applying comprehensive knowledge of clinical regulations, guidance, and standards.

Key Responsibilities :

• Provide expertise related to competence and certification.
• Monitor competence throughout clinical oversight via internal audits.
• Conduct and support audits of medical devices, managing escalated queries.
• Ensure compliance of processes and procedures for certification and Notified Bodies.
• Lead and mentor on medical device expertise within global schemes.
• Advise global heads, product specialists, and scheme managers.
• Develop and deliver training on medical device regulations, updates, and standards.

Qualifications and Experience :

• Extensive 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.
• Strong understanding of Medical Devices Regulations, guidance, and standards.
• Knowledge of clinical evaluation, data analysis, and study design.

Additional Information :

BSI is committed to excellence and diversity, offering competitive rewards, development opportunities, and flexible benefits. We promote a culture of client-centricity, agility, and collaboration. We support inclusive hiring practices and provide accommodations for applicants with disabilities. Interviews may be conducted face-to-face or virtually, depending on comfort and safety considerations.

• Seniority level : Mid-Senior level
• Employment type : Full-time
• Job function : Healthcare Provider
• Industry : Professional Services

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