Compliance Specialist (ISMS)

The Privacy Compliance Specialist is responsible for supporting the organization’s information security program, including, but not limited to, cybersecurity, GDPR, and HIPAA. This role is critical for the safety and security of products and organization. The successful applicant will collaborate closely with all teams within the organization.

KEY Roles & Responsibilities

• Works in conjunction with other members of the Information Security team to ensure the organization’s compliance with relevant privacy laws and regulations, including, but not limited to, ISO 27001, HIPAA, SOC 2, and GDPR.
• Responsible for coordinating the execution of Data Processing Agreements (DPAs) and Transfer Impact Assessments (TIAs), as applicable.
• Supports the Information Security Officer in conducting internal and external audits for ISMS, ISO 27001, HIPAA, and GDPR.
• Collaborates cross-functionally to implement technical and organizational measures to ensure data privacy.
• As directed, participates in investigations and impact assessments in the event of information security events
• Supports the Information Security Officer in communication to applicable regulatory authorities.

Minimum Qualifications, Education and Experience

• Bachelor’s degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
• A minimum of 2 years of experience in a regulated industry, preferably medical device. Software and/or software as a medical device experience a plus.
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
• Knowledge of the General Data Protection Regulation (GDPR), ISO 27001, and HIPAA. Knowledge of SOC 2 a plus.
• Experience with Regulatory Agency audits a plus
• Excellent written and oral communication skills