Senior Regulatory Compliance Specialist (Grecia, Costa Rica)

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 jnj.com . 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: Grecia, Costa Rica Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Senior Regulatory Compliance Specialist. Purpose: Conducts audits— planned and unplanned — to verify compliance with government regulations and applicable standards, in addition to company policies and procedures. Give guidance or advice to the organization as it relates to compliance, when required. You will be responsible for: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: It ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards Conducts internal audits of the Quality System for the purpose of verifying compliance with government regulations and applicable standards, in addition to company policies and procedures. Conducts good laboratory practice (GLP) audits as required. Gives guidance or advice as it relates to compliance with applicable standards and regulations. Performs re-audits to deficient aspects and to implement corrective and preventive actions as necessary and required. Assigns classifications to internal audit observations and documents audit results in written reports that can be distributed and reviewed by appropriate management. Monitors the effectiveness of corrective actions documented in observation responses. You can be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/or volunteer auditors. Reviews ownership of responses to audit observations, also acts as an advisor to other areas that are not being audited by him/her, giving advice on audit observation responses. Maintains audit report files, re-audit files and responses to audits carried out. Accompanies external auditors, representatives of government agencies or those required by management during the execution of an applicable audit. Conducts audits at other J&J sites when required by management. Complies with and reviews compliance metrics and communicates them to site management and the