Ensure that our products and services comply with all relevant regulations and standards, including GDPR, HIPAA, MDR
Work closely with the development team to ensure that our products meet the necessary compliance standards
Conduct regular audits and assessments to identify potential compliance issues
Develop and implement compliance policies and procedures
Provide training and support to team members on compliance-related matters
Stay up-to-date with changes in regulations and industry standards
Collaborate with external regulatory bodies as needed
Prepare and submit necessary documentation for regulatory approvals
Assist in the development of risk management strategies related to compliance
Monitor and report on compliance performance metrics
Assist in the development of compliance-related documentation, including policies, procedures, and training materials
Participate in cross-functional teams to ensure compliance is integrated into all aspects of product development and delivery
Assist in the development and implementation of compliance-related training programs for team members
Provide support and guidance to team members on compliance-related matters
Assist in the development and implementation of compliance-related communication strategies
Bachelor’s degree in a relevant field (e.g., law, business, healthcare)
3 to 5 years of experience in regulatory compliance, preferably in the medical device or healthcare industry
Strong understanding of GDPR, HIPAA, EMA, and FDA regulations
Excellent analytical and problem-solving skills
Strong attention to detail and ability to work independently
Excellent communication and interpersonal skills
Ability to work effectively in a team environment
Experience with compliance management software is a plus
Knowledge of risk management principles is a plus
Experience with project management methodologies is a plus
Ability to manage multiple projects and priorities effectively
Strong organizational skills and ability to meet deadlines
Ability to adapt to changing regulations and industry standards
Experience with data protection and privacy regulations is a plus
Knowledge of quality management systems (e.g., ISO 13485) is a plus
Experience with clinical trials and research compliance is a plus
Familiarity with software development processes and methodologies is a plus
Experience with AI and machine learning technologies is a plus
Knowledge of cybersecurity principles and practices is a plus
Experience with cloud computing and data storage regulations is a plus
Familiarity with electronic health records (EHR) and health information exchange (HIE) regulations is a plus
Experience with medical device software development and compliance is a plus
Knowledge of international regulatory requirements for medical devices is a plus