Compliance Manager (Healthcare)

About the project

The IT company Andersen invites an experienced Compliance Manager (Healthcare) to become a part of a successful team.

Andersen is a pre-IPO software development company that provides a full cycle of services. For over 19 years, we have been helping enterprises and middle-sized firms transform their businesses by creating effective digital solutions using innovative technologies.

Responsibilities

– Leading and developing the group compliance team across all three streams.

– Owning the compliance strategy, policies, controls, and risk register for the group.

– Ensuring compliance with healthcare regulations (HIPAA, GDPR, fraud and abuse, billing/coding), information security and privacy frameworks (ISO 27001, ISO 27701, SOC 2), and medical device/pharma regulations (ISO 13485, 21 CFR Part 820, MDR, GxP, FDA).

– Running internal risk assessments, audits, and compliance training across all streams.

– Leading certification initiatives (ISO 27001, ISO 27701, ISO 9001, ISO 13485, SOC 2, HITRUST, MDSAP).

– Managing relationships with external auditors, certification bodies, regulators, and accreditation bodies.

– Owning ISMS, PIMS, and QMS documentation and continuous compliance.

– Developing and launching compliance services for clients (audits, readiness programs, DPO-as-a-Service).

– Supporting sales and presales in designing compliance solutions and overseeing delivery of compliance consulting projects.

– Owning medical device/pharma regulatory compliance, including 510(k) submissions, FDA guidance, GxP validation, and IQ/OQ/PQ.

– Reporting regularly to senior management and the board on compliance status and risk exposure.

Requirements

– 8+ years in compliance, regulatory affairs, quality, information security, or risk management.

– At least 3 years in a healthcare-related environment.

– Experience managing or mentoring compliance teams across more than one business line.

– Deep knowledge of HIPAA, GDPR, and global healthcare regulations.

– Strong working knowledge of ISO 27001, ISO 27701, and SOC 2.

– Strong working knowledge of ISO 13485, ISO 9001, 21 CFR Part 820, MDR, and GxP.

– Hands-on experience with ISO 14971, IEC 62304, IEC 62366, FDA compliance, 510(k), and IQ/OQ/PQ.

– Experience in at least two of the following: healthcare provider, health tech/software, medical device/pharma, compliance consulting.

– Strong documentation, process management, and communication skills.

– Proven cross-functional work with Legal, HR, Security, Quality, Regulatory, Clinical, Product, and leadership.

– English proficiency at Upper-Intermediate+ level or higher.

Nice to have

– CHC, CHPC, CHRC, CIPP, CIPM, ISO 27001 Lead Implementer/Auditor, CISM, CISA, CQA, RAC, or equivalent certifications.

– Experience building compliance services in consulting or technology.

– Knowledge of NIST, COBIT, CIS, HITRUST CSF, ISO 14971.

– Experience with MDSAP, HITRUST, or other healthcare certifications.

– Experience leading regulatory inspections, notified body audits, or accreditation surveys.

– Experience in a group, holding, or multi-entity environment.

Why join us

• Andersen cooperates with such businesses as Samsung, Johnson & Johnson, Ryanair, Europcar, TUI, Verivox, Shypple, etc.
• We offer the opportunity to gain experience in developing business relationships with the world's largest brands, as well as large-scale projects using cutting-edge technologies.
• Interesting and high-profile deals, negotiation practice, and communication with C-level people.
• The most important thing that we value in our employees is a commitment to continuous learning. The company supports them in this and gives them access to the best educational platforms, seminars, and practices. In addition, for over 19 years, Andersen has assembled a huge knowledge base and established a robust resource management institution.
• We have been strengthening our expertise since 2007. During this time, we have formed excellent teams with streamlined processes, where you can learn something new from your colleagues every day and enjoy your work.
• We at Andersen have many different ways to grow. You can improve as a specialist or a manager, and all your activities will be decently rewarded.