Principal Compliance/Audit Specialist

MiniMed•Northridge, CA

1d•Onsite

About The Position

Are you passionate about driving compliance excellence and strengthening audit readiness within a highly regulated medical device environment? Join MiniMed as a Principal Compliance/Audit Specialist and play a key role in strengthening compliance, audit readiness, and quality system effectiveness within a regulated medical device environment. In this role, you will lead audits, compliance assessments, and risk evaluations; partner with cross-functional teams to address gaps and implement corrective actions; and provide expert guidance on regulatory requirements. The ideal candidate is an experienced compliance professional with strong auditing, regulatory, and stakeholder management skills who is passionate about driving continuous improvement and protecting patient safety. On-site role requiring minimum 4 days per week in Northridge, CA.

Requirements

Bachelor’s degree with 7+ years’ relevant experience, or Advanced degree with 5 years of experience.
Experience in medical device quality and regulatory compliance; strong knowledge of FDA, ISO 13485, and other applicable regulatory requirements.
Experience in auditing, risk assessment, and CAPA effectiveness.
Experience supporting regulatory inspections and driving inspection readiness initiatives.
Certified Auditor certification (ASQ CQA, ISO 13485 Lead Auditor, or equivalent)

Nice To Haves

Risk management: Demonstrated knowledge and practical application of medical-device risk management principles, including the ability to evaluate risk-management processes, risk analyses, risk controls, residual risk, risk-benefit determinations, and risk-management files; challenge the adequacy and consistency of risk-based decisions; and assess whether changes to products, processes, suppliers, or the QMS have been appropriately evaluated for risk and supported by objective evidence.
Ability to analyze complex data and communicate findings to leadership; and strong collaboration, influencing, and stakeholder management skills.
Familiarity with global medical device regulations and standards, including EU MDR and international compliance requirements.
Experience developing compliance training, awareness programs, and quality culture initiatives.
Cybersecurity experience involving medical devices, such as IEC 81001-5-1FDA cybersecurity expectations, threat modeling, or vulnerability management.
Experience with IEC 62304 software lifecycle processes.
Experience with IEC 62366 usability engineering.

Responsibilities

Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
Develop and implement programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.