Digital Compliance Lead @
2 days ago
Required Qualifications:
- Demonstrated experience in managing change in complex, global environments.
- Ability to build strong relationships and navigate through ambiguity.
- Experience with regulatory requirements and risk management within the healthcare or medical device sectors.
- Strong problem-solving skills with a focus on delivering business impact in a large global organization.
- 5+ years of experience in quality assurance for software development in large, global IT environments, ideally in the medical device industry.
- Practical knowledge of 21 CFR Part 11, 21 CFR Part 820, EMA Annex 11, EMA MDR, IVDR, and ISO 13485.
- Experience in quality assurance for Software as a Medical Device (SaMD) development.
- Strong understanding of risk management principles and software development life cycle methodologies, including Agile.
- Knowledge of privacy regulations (e.g., GDPR, HIPAA) and their application to service providers.
- Experience in audits, IT security, and privacy management is desirable.
- 5+ years of experience in quality assurance for software development in large, global IT environments, ideally in the medical device industry.
Position Overview: We are seeking a highly skilled Digital Compliance Lead to join our dynamic Informatics community. This is an exciting opportunity to work with a diverse team of professionals who are passionate about advancing healthcare solutions. The role focuses on ensuring that our partner's digital environment and products comply with regulations, are secure, and manage risks effectively. You will play a key role in evaluating third-party services, supporting digital compliance processes, and leading risk management efforts across global teams.
This role offers the chance to make a real impact on global healthcare challenges by ensuring digital compliance across a wide array of services and products. If you are driven by solving complex problems and have a passion for healthcare and compliance, we encourage you to apply
Terms & Conditions:
- B2B contract
- Fully remote
- Work on your own devices
- 2 interview
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