Regulatory Compliance Specialist

Position: Staff Regulatory Compliance Specialist
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

Professional

All Job Posting Locations:

San Jose, California, United States of America, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is currently recruiting a Staff Regulatory Compliance Specialist! This position can be located in Santa Clara or San Jose, California.

Position Summary:

The Staff Compliance Engineer (Senior Analyst, Enterprise Compliance) will support, maintain, and lead when necessary, the Internal Audit Program to help the site sustain a state of readiness to applicable regulatory requirements. Leads and maintains the assigned Compliance functions to ensure compliance to applicable regulations and directives such as 21 CFR 820, 21 CFR 4, ISO 13485/EN ISO 13485, ISO 14971/EN ISO 14971, European Medical Device Directive and European Medical Device Regulation, Canadian Medical Devices Regulations SOR/98-282, ANVISA Technical Regulations of Good Manufacturing Practices of Medicinal Products and In Vitro Diagnostic Products, Resolution RDC 665, Japan Ministry of Health, Labour and Welfare of Japan Ordinance No.

169, Australia Therapeutic Goods (Medical Devices) Regulations, and any other regulations or standards applicable to the site.

Participates in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards and directives in accordance with the internal audit schedule. Leads inspection readiness activities and actively participates in conduct of external quality system audits and inspections. Supports preparation of external audit and inspection responses. lead compliance projects/initiatives at the sites and serves on cross-site project teams consistent with company goals and objectives, to improve overall compliance performance to established metrics and requirements.

Manages assigned internal and external audit observations to ensure identified gaps are closed in a timely manner.

Key

Duties & Responsibilities:

External inspection readiness and associated activities. Support site audit readiness activities to ensure inspection readiness at all time.

* Supports external audits and mock inspections: e.g. Notified Body, Ministry of Health country inspections, FDA, State Inspections, J&J Corporate Audits for site.

* Executes site inspection readiness actions/tools o Participates in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME's, etc.).

* Assesses the risk and applicability of audit observations from other J&J facilities to determine impact to the site.

* Provides timely information to support the inspection process

Internal Audit Program and Management Execution o Executes internal audits, as a team or lead auditor, against established internal audit procedures.

* Ensures adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.

* Drives compliance and improvement in audit metrics.

Enterprise / Sector Support o Connects and collaborates with other region's compliance teams.

* Conducts audits at other sites as needed.

Metrics Collection and Reporting

* Creates reports and…