Regulatory Compliance Agent.
Responsibilities
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
Requirements
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
Knowledge of quality management systems (e.g., ISO 13485) is a plus
Communication Skills
Must be able to communicate effectively with business and technical teams
Must have strong presentation skills
Must be able to collaborate with cross-functional teams
Must be able to mentor and guide junior team members
Must be able to adapt communication style to different audiences
Must be able to work in an Agile operating model
What We Offer
Competitive compensation
Possibility to work remote when desired
Work with the best professionals in the area
Great work environment in our Cluj Napoca office
Private healthcare insurance plus other benefits