Clinical Affairs Manager
Behavioral Health Market Context
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Job Description
sponsibilities:
• Write, review and manage clinical protocols, study plans and clinical reports.
• Ensure all clinical documentation adheres to GCP, ISO 13485, FDA and MDR requirements.
• Collaborate with regulatory, quality and R&D teams to support FDA submission and audits.
• Maintain clinical documentation and signatory records according to SOPs.
• Help lead clinical studies from First-in-Human through IDE and post-market studies.
• Support clinical operations by monitoring study progress, timelines and data quality.
Qualifications/Education:
> Bachelor's degree in a relevant scientific discipline or equivalent; advanced degree preferred.
Experience:
> Minimum 5 years in Clinical Affairs with Class II and III medical device products, preferably with implantable, vascular or neurovascular devices.
> Proven experience in clinical protocol development, clinical reports and regulatory submissions.
Skills:
> Strong understanding of clinical operations, study management, regulatory requirements (FDA,
MDR) and quality system (ISO13485).
• Write, review and manage clinical protocols, study plans and clinical reports.
• Ensure all clinical documentation adheres to GCP, ISO 13485, FDA and MDR requirements.
• Collaborate with regulatory, quality and R&D teams to support FDA submission and audits.
• Maintain clinical documentation and signatory records according to SOPs.
• Help lead clinical studies from First-in-Human through IDE and post-market studies.
• Support clinical operations by monitoring study progress, timelines and data quality.
Qualifications/Education:
> Bachelor's degree in a relevant scientific discipline or equivalent; advanced degree preferred.
Experience:
> Minimum 5 years in Clinical Affairs with Class II and III medical device products, preferably with implantable, vascular or neurovascular devices.
> Proven experience in clinical protocol development, clinical reports and regulatory submissions.
Skills:
> Strong understanding of clinical operations, study management, regulatory requirements (FDA,
MDR) and quality system (ISO13485).
Qualifications
- •> Minimum 5 years in Clinical Affairs with Class II and III medical device products, preferably with implantable, vascular or neurovascular devices
- •> Proven experience in clinical protocol development, clinical reports and regulatory submissions
- •> Strong understanding of clinical operations, study management, regulatory requirements (FDA,
- •MDR) and quality system (ISO13485)
Benefits
Responsibilities
- •Lead the development and execution of clinical protocols and clinical evaluation reports, ensuring compliance with regulatory and quality standards
- •Writes and implements protocols and plans necessary to support corporate objectives
- •This role bridges clinical operations with regulatory strategy, supporting the Company's medical and regulatory objectives across pivotal and post-market studies
- •Write, review and manage clinical protocols, study plans and clinical reports
- •Ensure all clinical documentation adheres to GCP, ISO 13485, FDA and MDR requirements
- •Collaborate with regulatory, quality and R&D teams to support FDA submission and audits
- •Maintain clinical documentation and signatory records according to SOPs
- •Help lead clinical studies from First-in-Human through IDE and post-market studies
- •Support clinical operations by monitoring study progress, timelines and data quality
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