Cybersecurity Product Compliance Manager

1 week ago

Bedford, Massachusetts, United States Werfen Full time

Overview:

Werfen

Werfen is a dynamic, family-owned enterprise established in 1966 in Barcelona, Spain. We are a global frontrunner in specialized diagnostics across various domains, including Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplantation. Through our Original Equipment Manufacturing (OEM) division, we engage in the research, development, and production of tailored assays and biomaterials. Our operations span 30 countries directly and over 100 territories through distributors. Our Headquarters and Technology Centers are strategically located in the US and Europe, employing a workforce exceeding 7,000 individuals.

Our achievements stem from a concentrated focus on these swiftly advancing diagnostic fields, our unwavering commitment to clients, and our passion for innovation and quality. We are dedicated to equipping healthcare professionals with the most effective and comprehensive solutions to enhance hospital efficiency and improve patient outcomes.

Position Summary:

The Werfen Product Privacy and Security Program operates as a shared service model, overseeing Cybersecurity and Privacy by Design, Compliance, Security Testing, and Incident Response. As a Cybersecurity Product Compliance Manager at Werfen, you will be accountable for the cybersecurity and privacy functions associated with our products. This role collaborates with Werfen Projects to uphold the product privacy and security framework. You will serve as a trusted partner to Project Teams, working closely with Quality and Regulatory functions.

Key Responsibilities:

  • Act as a representative of the Werfen Product Privacy and Security Office.
  • Lead cross-functional teams in executing all technical elements of product cybersecurity initiatives.
  • Engage with product development teams to ensure cybersecurity and privacy considerations are integrated into product design.
  • Provide expertise in cybersecurity and privacy during Risk Assessments, including:
    • Management of cybersecurity threats,
    • Ongoing technical analysis and monitoring of cybersecurity indicators.
  • Participate in customer assurance activities, which encompass Product Security communications such as:
    • Product Labeling,
    • Addressing security inquiries,
    • Managing complaint and vulnerability reports,
    • Delivering consistent cybersecurity and privacy guidance to Werfen and its clients.

Qualifications:

Essential Knowledge & Experience:

  • 12-15 years of experience in Cybersecurity and/or Privacy Compliance.
  • A minimum of 5 years leading product cybersecurity projects and risk management in the medical device or healthcare sector.
  • Experience in cross-functional cybersecurity initiatives, including Product Defense in Depth, security technologies, regulatory compliance, and incident response.
  • Familiarity with domain-specific standards and practices regarding privacy and product security (ISO 2700x, NIST 800 Series Special Publications).
  • Knowledge of laws and regulations related to cybersecurity, privacy, data protection, and breach notification (e.g., FDA cybersecurity guidelines, HIPAA, GDPR, ISO 13485).
  • Experience in designing or managing software products utilizing Secure SDLC methodologies.
  • Comprehensive understanding of securing and hardening Windows and Linux operating systems.
  • In-depth knowledge of networking and network security.

If you are passionate about continuous learning and thrive in a challenging environment, we encourage you to consider this opportunity.

Werfen is an Equal Opportunity employer, committed to fostering a diverse workplace. We strictly prohibit unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable law.

We operate globally, with a significant annual revenue and a dedicated workforce that embodies the Werfen team.

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