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Compliance Manager (m/w/d)

Job description

Join our international team and take ownership of compliance, information security, and data protection standards. Collaborate closely with internal teams and external stakeholders to design, implement, and maintain robust policies that protect our organization and safeguard patient data.
As a Compliance Manager, you will play a key role in ensuring that our processes meet the highest regulatory standards. You will lead compliance training programs, conduct audits, and provide regular reports to management on compliance performance. Your guidance will ensure the continued integrity and security of our operations as we navigate an ever-evolving regulatory landscape.
Why should you join us?
At smartpatient, our close-knit team is committed to developing a high-quality product that improves the lives of millions of people taking medications. Everyone is encouraged to take ownership of their work and create an open environment where new ideas are welcome, driving both the quality of our product and personal development. Fostering a culture that values honest communication and cooperation ensures our team members from across the globe are happy, motivated and engaged. This approach helps us achieve our company ambitions.

Job requirements

Your tasks:

  • Develop and maintain management systems to ensure compliance.
  • Maintain our Quality Management System (ISO 13485, medical device development).
  • Monitor relevant news, legal developments, and potential security threats to ensure the company’s preparedness.
  • Conduct regular internal audits.
  • Manage and coordinate company-wide training on compliance, information security, and data protection.
  • Maintain records on compliance, security, and risk management for both internal review and external regulatory authorities.
  • Act as the primary point of contact for compliance, information security, and data protection queries and incidents.
  • Lead compliance-related meetings with cross-functional teams and ensure proper communication of relevant updates.
  • Support the creation and maintenance of technical and legal documentation to ensure compliance of product development with market regulations.
  • Evaluate suppliers and third-party services for compliance with quality and security standards.
  • Ensure continuous improvement of processes based on audit feedback, internal reviews, and regulatory changes.

Must-haves

  • Experience in Compliance Management: At least 2-3 years of experience overseeing compliance, regulatory adherence, and risk management processes within a healthcare or technology-related field.
  • Experience with Audits and Certifications: Minimum of 2-3 years of hands-on experience in preparing, conducting, and passing compliance audits. Proven success in maintaining relevant certifications (e.g., ISO 13485 for medical devices, ISO 27001).
  • Project Management Skills: Around 2 years of experience managing compliance projects and cross-functional teams, ensuring deliverables and timelines are met.
  • Familiarity with Legal and Regulatory Frameworks: Solid understanding of applicable laws, especially in data protection (GDPR), anti-bribery, and information security standards (ISO).
  • Communication Skills: Proven ability to communicate effectively with both internal stakeholders and external parties, including regulatory authorities and suppliers.
  • Analytical and Problem-Solving Skills: Strong track record of identifying compliance risks, addressing violations, and implementing preventive measures.
  • Attention to Detail: Essential for handling legal documents, regulatory reports, and risk assessments.
  • Adaptability to Regulatory Changes: A proactive approach to staying updated with evolving laws, industry standards, and best practices.
  • Native German and fluent English.

Nice-to-haves:

  • Experience with technical documentation for software as a medical device.
  • Previous leadership experience.
  • Ability to assess security vulnerabilities and provide guidance on migration.

What do we offer?

  • A job with a purpose, supporting millions living with chronic diseases.
  • A start-up spirit combined with grown-up structures and facilities.
  • Top-notch equipment and working environment.
  • Competitive compensation in line with your track record.
  • Training and development budgets (e.g., for conferences).
  • Regular team and company-wide events.
  • Flexible mobile working policy.
  • Employee Discounts within Shop Apotheke Group.
  • Urban Sports Club Membership.
  • Free drinks, fruit, and cereals.

We look forward to receiving your CV and cover letter!

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Compliance Manager (m/w/d)

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München
Vollzeit, Unbefristet

Veröffentlicht am 16.10.2024

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