Project Manager; Regulatory​/Cybersecurity

Project Management involving regulatory / cybersecurity related to hardware platforms and digital devices. (MUST HAVE.)

We are looking for a Sr. Project Manager, who will contribute to the success of our client's Regulatory Affairs / Compliance / IT Security Team, applying their expertise in Project Management to support the achievement of team and company goals and deliver innovative, reliable solutions. In this role, the successful candidate will collaborate effectively with colleagues and cross-functional teams, demonstrate strong problem-solving and decision‑making skills, and maintain a commitment to professional excellence, quality and continuous improvement.

• Lead the development and implementation of cybersecurity compliance strategies for products with digital elements.
• Coordinate vulnerability reporting, technical documentation, and conformity assessment procedures as required by relevant security rules and regulations.
• Manage project timelines, resources, and stakeholder communications.
• Liaise with product development, IT, legal, and external partners to ensure full supply chain compliance.
• Monitor regulatory changes and update internal policies and procedures accordingly.
• Prepare and present compliance status reports to senior management and regulatory bodies.
• Mentor team members on security regulation requirements and best practices.

• Develop and maintain project plans for medical and electronic hardware device Cybersecurity compliance initiatives.
• Oversee the creation and management of Software Bill of Materials (SBOMs) and ensure their accessibility and accuracy.
• Ensure all products meet cybersecurity requirements throughout their lifecycle, including secure design, vulnerability management, and incident response.
• Coordinate internal and external audits and manage remediation activities.
• Facilitate training and awareness programs for CRA compliance.
• Identifying key stakeholders and understanding their expectations for a successful project.
• Monitoring progress on schedule, budget and technical output, as well as scheduling to identify critical path(s) and major risks. You’ll be proactively managing risks and employing strategies to address those risks.
• Driving teams to execute on tasks and deliverables, as well as developing a sense of urgency when key deliverables are jeopardized. You’ll also be facilitating problem solving and meetings to address obstacles.
• Working with core team and functional leader expertise when faced with critical decisions and hold them accountable to program commitments.
• Facilitates communication to key stakeholders on project performance.
• Ensuring the project scope includes input from all functional disciplines including marketing, engineering, operations, quality, compliance, and service.
• Conducting project Gate reviews and business team meetings.
• Continuously evaluate processes for improvements in efficiency, quality, and safety.
• This job description is not intended to be all-inclusive. Responsibilities may evolve over time, and other related duties may be assigned to meet the ongoing needs of the company.

• Bachelor’s degree in Engineering, Computer Science, Information Security, or related field.
• Minimum 10 years of project management experience, with several years in regulatory compliance or cybersecurity as they relate to hardware platforms, digital devices, etc.
• Must have successfully managed multiple high‑technology hardware/software projects from concept through commercialization using a stage‑gate process.
• Highly effective communicator, using both in spoken and written forms; sharp interpersonal skills who understand how to communicate across varied audiences in a climate of debate.
• Demonstrated experience with EU regulations, such as the Cyber Resilience Act or similar frameworks.
• Strong leadership, decision‑making, and communication skills.
• Experience managing cross‑functional teams and complex projects.

• MBA, M.S. or PhD in Engineering or Technical degree.
• Experience with CE marking, SBOM management, and supply chain cybersecurity.
• Familiarity with ISO/IEC 27001, EUCC certification, and other cybersecurity standards (IEC 62443)

• Primarily office/lab/manufacturing environment.
• This is an “in‑office” position working closely with a variety of senior engineering staff.
• Exposure to regulatory and audit environments.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this role.