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Regulatory Compliance Agent.

Cluj-Napoca, Romania | Remote
Full Time

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