Senior 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 MedTech, 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 more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Athens, Georgia, United States of America, Cornelia, Georgia, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Regulatory Compliance Specialist! This position can be located in Cornelia or Athens, Georgia. 

Position Summary: 

Under the supervision of the Regulatory Compliance Manager, the Senior Regulatory Compliance Specialist is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements. 

The Regulatory Compliance Specialist will lead and maintain the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements.  Leads and maintains assigned Compliance functions to ensure compliance to applicable regulations and directives such as 21CFR 820, 21 CFR 4, ISO 13485/EN 1SO 13485, ISO 14971/EN ISO 14971, European Medical Devices Directive, Canadian Medical Devices Regulations SOR/98-282, ANVISA RDC No.

665 (2022), Provides for Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products, Japan Ministry of Health, Labor 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 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.  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. 

Conducts audits to good manufacturing practices, international organization for standardization and any other applicable standard. 

Key Responsibilities: 

Coaches more junior colleagues in techniques, processes, and responsibilities.​ 

Understands and applies Johnson & Johnson’s Credo and ...