Responsibilities
- Lead and manage the quality and regulatory affairs team.
- Develop and implement quality management systems.
- Ensure compliance with relevant regulations and standards.
- Coordinate with internal and external stakeholders.
- Manage regulatory submissions and approvals.
- Conduct risk assessments and implement mitigation strategies.
- Oversee clinical evaluations and post-market surveillance.
- Provide training and support to the team on regulatory requirements.
- Maintain documentation and records for audits and inspections.
- Collaborate with R&D and engineering teams for product development.
- Monitor and report on quality and regulatory performance metrics.
- Stay updated with changes in regulatory landscape.
- Ensure timely and accurate reporting to regulatory authorities.
- Implement and maintain quality management systems.
- Develop and implement regulatory strategies.
- Ensure compliance with international regulatory requirements.
- Manage vendor and supplier relationships.
- Conduct internal audits and assessments.
- Provide guidance on regulatory compliance to the team.
- Ensure compliance with data protection and privacy regulations.
- Develop and implement quality improvement plans.
- Manage regulatory inspections and audits.
Nice to Have
- Experience in the medical device industry.
- Familiarity with AI and machine learning technologies.
- Knowledge of ISO 13485 and ISO 14971 standards.
- Experience with CE marking and FDA regulations.
- Proficient in project management tools and methodologies.
- Familiarity with risk management frameworks.
- Experience with post-market surveillance and clinical evaluations.
- Knowledge of data protection and privacy regulations.
- Ability to work in a fast-paced and dynamic environment.
- Experience with regulatory submissions and approvals.
- Proficient in conducting internal audits and assessments.
- Knowledge of international regulatory requirements.
- Ability to stay updated with changes in the regulatory landscape.
- Experience with regulatory inspections and audits.
- Proficient in quality improvement strategies.
- Ability to provide training and support to the team.
- Experience with maintaining documentation and records.
- Strong problem-solving and analytical skills.
- Ability to develop and implement regulatory strategies.
Compensation
Not specified
Work Arrangement
Hybrid
Team
Collaboration with cross-functional teams
Your Profile
- You have a degree in a relevant field, such as engineering, computer science, or a related discipline.
- You possess a strong background in quality and regulatory affairs for medical software.
- You have experience in leading and managing teams in a regulatory environment.
- You are familiar with AI and machine learning technologies.
- You have a deep understanding of international regulatory requirements.
- You are proficient in risk assessment and mitigation strategies.
- You have experience with clinical evaluations and post-market surveillance.
- You are knowledgeable about data protection and privacy regulations.
- You have strong leadership and management skills.
- You possess excellent communication and interpersonal skills.
What We Offer
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- The chance to work on cutting-edge AI medical software.
- A competitive compensation package.
- A hybrid work arrangement for flexibility.
- The opportunity to make a significant impact in the medical field.
- A supportive and inclusive team culture.
- Access to state-of-the-art technology and resources.
- The chance to work on innovative projects.
- A focus on quality and regulatory compliance.
Not specified
