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Regulatory Affairs Director
hace 2 semanas
Conceivable Life Sciences
is pioneering the world's first AI-powered, automated IVF
laboratory, revolutionizing reproductive healthcare through cutting-edge robotics and
artificial intelligence. We are seeking a passionate and dedicated
Regulatory Affairs
Director
to lead our comprehensive regulatory compliance strategy across multiple
frameworks including ISO standards, and cybersecurity certifications.
Responsibilities:
- Lead multi-framework regulatory strategy encompassing SOC2 type II compliance, ISO 9001/13485 quality management systems, HITRUST cybersecurity framework, and GAMP.
- Collaborate with cross-functional teams to ensure integrated compliance approach across products - hardware and software.
- Manage regulatory submission timelines, documentation requirements, stakeholder communications for complex medical device applications.
- Establish and maintain Design Controls and quality management systems supporting multiple regulatory frameworks.
- Support creation of comprehensive documentation cybersecurity frameworks. Interface with clinical partners and key opinion leaders to support regulatory strategy development.
Qualifications:
- BS in Biomedical Engineering, Computer Science or related engineering discipline.
- 4-5 years of proven experience in medical device regulatory affairs and compliance knowledge of Design Controls (21 CFR 820), ISO 13485, and medical device quality management systems.
- Experience with Computer System Validation (CSV) and GAMP 5 principles.
- Strong understanding of risk management principles (ISO and hazard analysis methodologies.
- Excellent project management skills with ability to manage multiple concurrent regulatory streams.
- Outstanding written and verbal communication skills for regulatory submissions and stakeholder management.
- Fluent in both English and Spanish
