Description
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 & ComplianceJob Sub Function:
Enterprise ComplianceJob Category:
ProfessionalAll Job Posting Locations:
Ciudad Juarez, Chihuahua, MexicoJob 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 Surgery
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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
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 STAFF REGULATORY COMPLIANCE SPECIALIST to be in Ciudad Juarez, Ethicon Inc.
Purpose:
The Regulatory Compliance Specialist, under the supervision of the Regulatory Compliance Manager, 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.
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:
- Support external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, from room/back room arrangements, identifying/preparing SME’s, etc.
- Support external audits/inspections of the site e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, or JJRC/ERC.
- As required, assess the risk and applicability of external audit/inspection observations from other J&J facilities to determine impact to the site.
- Support mock external audits/inspections as part of External Audit/Inspection Readiness activities.
- Provide timely information to support the external audit/inspection process.
- Provide guidance to prepare responses to any regulatory agency notification or correspondence associated with the site.
- Provide guidance to ensure timely and adequate responses to external audit/inspection observations related to the site, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
- Ensure timely and accurate reporting and publishing of external audit metrics. Drive compliance and improvements in metrics targets.
- Execute internal audits according to the established internal audit procedures.
- Ensure internal audit results are reported to management having responsibility for the matters audited.
- Ensure timely and adequate responses to internal audit observations, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure
- Ensure timely and accurate reporting and publishing of internal audit metrics. Drive compliance and improvements in metrics targets.
- Ensure documentation and records related to the internal audit program are maintained.
- Ensure all quality system elements/processes applicable to the site are audited and appropriate actions are taken to meet the business and regulatory requirements.
- Participate in JJRC audits as requested.
- Connect and collaborate with the compliance teams of other sites, regions and business groups.
- Assure that internal and external audit metrics are consistently and accurately captured, and that they are reported and published at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
- Drive compliance and improvements in metrics targets.
- Create reports and communicate performance against metrics to key stakeholders.
- Highlight/communicate adverse trends in metrics, and take risk based action to remediate.
- Escalate quality issues in accordance with established procedures.
- Support implementation of new/revised regulations and standards for the site.
- Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
- Provide input into Site Management Reviews and Data Review Boards (e.g., internal audits.) to allow meaningful reviews.
- Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, and Manufacturing.
- Provide/coordinate regulatory compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational/training strategies.
- Perform performance appraisals and establish goals/objectives and development plans for direct reports.
- Comply with all environmental, safety and occupational health policies and ensure all direct reports comply with those requirements.
- Comply and ensure compliance of employees under area of responsibility with the Quality System regulations, standards, company policies and procedures.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
The Staff Regulatory Compliance Specialist develops or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical issues. In addition to those activities pertaining to the Senior Level of the position, the Staff Regulatory Compliance Specialist may act as an emerging authority in the regulatory compliance or related field, exercising considerable latitude in determining objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, assure compliance with Quality System and regulatory requirements. The Staff Regulatory Compliance Specialist has knowledge of regulations and standards applicable to medical devices or pharmaceuticals.
EXPERIENCE AND EDUCATION
- Bachelor degree is required
- Experience in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical), regulated medical device operation preferred.
- Experience in Quality, Manufacturing or Engineering roles is preferred.
- Auditing experience is preferred.
- Previous experience in supervisory position is preferred.
JOB EXPERIENCE: Generally, requires 5-8 years related experience.
KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and
AFFILIATIONS
- Knowledge of FDA/ISO/Health Authority Quality System regulations and standards.
- Current Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification is preferred. Ability to become certified within 1 year if required.
- Training in Process Excellence/Six Sigma tools and methodologies or Certification is preferred.
- Good written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.
- Accomplish objectives in a timely manner with limited or without day to day supervision.
- Good interpersonal skills; customer service oriented.
- Computer Literate. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. Experience with Microsoft Project or Minitab is preferred.
- Experience in leading and managing projects preferred.
LOCATION & TRAVEL REQUIREMENTS
- Primary location: Juarez, Mexico
- Expected travel for both domestic and international: 10%
Required Skills:
Preferred Skills:
Audit and Compliance Trends, Audit Management, Audit Reporting, Business Behavior, Business Writing, Coaching, Communication, Compliance Frameworks, Compliance Management, Compliance Risk, Corporate Investigations, Critical Thinking, Legal Function, Legal Services, People Centricity, Problem Solving, Process Improvements