Clinical Affairs Manager
Clinical Affairs Manager
Posted on :
28-03-2025
Employer Active
1 Vacancy
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Job Description
Skills & Experience
- Degree in life sciences biomedical engineering pharmacy medicine or health technology sciences (minimum Masters degree).
- At least 3 years of experience in Clinical Affairs within the medical device industry
- Indepth knowledge of applicable regulations (ISO 14155 MDR 2017/745 GCP)
- Strong project management skills with the ability to lead multiple projects simultaneously
- Writing analysis and synthesis skills
- Bonus: experience working in a startup environment.
Key Responsibilities
Planning and Management of Clinical Studies
- Define and execute the clinical strategy in accordance with regulatory requirements (US EU)
- Design plan and oversee clinical investigations (pre and postmarketing) in compliance with regulatory requirements (ISO 14155 MDR 2017/745 GCP)
- Collaborate with crossfunctional teams (Top Management R&D Regulatory Affairs Quality Assurance) to align clinical activities with product development goals
- Manage relationships with investigators ethics committees regulatory authorities CROs and other partners/service providers
- Coordinate the selection of investigation centers
- Monitor PostMarket Clinical Followup (PMCF) activities to ensure continuous compliance.
Clinical Documentation and Regulatory Compliance
- Lead the preparation review and submission of clinical documentation including Clinical Evaluation Plan (CEP) Clinical Evaluation Report (CER) Investigator Brochure clinical protocols and other clinical documentation.
- Oversee the submission of clinical studies to regulatory agencies and ethics committees in compliance with U.S. and EU regulatory guidelines
- Ensure all clinical documentation adheres to the highest standards of regulatory clarity scientific accuracy and quality.
- Ensure compliance with GDPR requirements regarding patient data management
- Monitor and analyze clinical data in collaboration with medical and statistical teams.
Who We Are
Chipiron is revolutionizing the medical imaging industry by developing light and easily deployable MRI machines powered by an ultrasensitive quantum detection system. Our mission is to make MRI accessible to everyone everywhere. Were a team of engineers based in the heart of Paris and we have only one obsession: building things people want.
Our Culture
- Collaborative DecisionMaking;
- High Standards and Autonomy: We maintain high expectations for our team members and offer complete autonomy coupled with incentives tied to the companys success fostering a culture of ownership and accountability;
- Value of Humility: We prioritize seeking the truth over being right;
- EnglishFirst International Team.
Employment Type
Full Time
Key Skills
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