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:
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:
Auris health Inc a member of the Johnson & Johnson Family of Companies is recruiting for a Principal Regulatory Compliance Specialist! This position will be located in San Jose, California.
Position Summary:
Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, endoluminal intervention and general surgery. This includes the MONARCH®, OTTAVA and Polyphonic platform, a first-of-its-kind robotic technology and digital solutions.
Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
SECTION 1: JOB 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.
SECTION 2: DUTIES & RESPONSIBILITIES*
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Summary of Technical Duties:
- Responsible for the data analysis and reporting for the sites and identify compliance issues
- Lead, participate and/or support as needed in projects associated with audit process and application for the sites.
- Lead/ participate and/or support as needed in root cause investigations and quality systems and compliance improvements that results from Internal/External Audits, management reviews and any other NC/CAPA system indicators
- Support Process Excellence projects such as Lean Six Sigma of both new and existing processes, including but not limited to, quality improvements, cost reductions and productivity improvements.
- Complete statistical analysis of data for decision making.
- Review of manufacturing processes, instrument and equipment qualifications, (IQ/OQ/PQ), design history file, engineering documentation, etc.
- External inspection readiness and associated activities.
- Support site audit readiness activities to ensure inspection readiness at all times.
- Supports external audits and mock inspections: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.
- Executes site inspection readiness actions/tools
- 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
- Executes internal audits, as a team or lead auditor, against established internal audit procedures, which can include but is not limited to audits of manufacturing processes, process/software validations, design controls, etc.
- Ensures adequate corrective actions for internal audits, including robust root cause 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
- Connects and collaborates with other region’s compliance teams.
- Conducts audits at other sites as needed.
- Execute and/or supports Process Excellence projects as well as Lean Six Sigma of both new and existing processes, including but not limited to, quality improvements, cost reductions and productivity improvements.
- Metrics Collection and Reporting
- Trends, analyzes, creates reports and communicates performance against metrics to key stakeholders.
- Highlights/communicates adverse trends in metrics and take risk-based action to remediate.
- Escalations
- Escalates items in accordance with established procedures.
- External Standards and Regulations
- Supports implementation of new external standards/regulations for the site.
- Maintains current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
- Site Management Review and Quality Reviews
- Provides input (e.g., internal and external audit results/status) into Site Management Reviews, Corrective Action Review Boards and Plant Quality Reviews to allow meaningful review.
- Participates in reviews as required.
- Other tasks
- Establishes strong connection and collaboration with business partners at the site, (e.g. Quality Operations, Facilities, Training, Engineering and Manufacturing).
- Provides compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
- Supports and promotes the safety and environmental objectives of the facility. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
- 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
SECTION 3: EXPERIENCE AND EDUCATION*
- Generally, Requires 5 Years Work Experience
- Bachelor’s degree or equivalent required; concentration in Engineering or technical field preferred.
- Bachelor’s degree or equivalent with 4 - 6 years of experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry is required.
- Experience in Quality, Manufacturing or Engineering roles will be preferred.
- Experience leading internal quality system audits is preferred.
- Experience leading or managing an internal audit program is preferred.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
- Knowledge of FDA/ISO/Health Authority Quality System regulations and standards highly preferred.
- Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs), European Medical Device regulations(EUMDR) and Information Security Management Systems, Medical Device Single Audit Program.
- Position requires proven leadership skills in associate involvement and teamwork, initiative, creativity, assertiveness, attention to detail, and excellent interpersonal skills.
- Good written and oral communication skills as well as report writing, presentation and training
- Ability to accomplish objectives in a timely manner without day-to-day supervision.
- Ability to analyze complex data and integrate multi-disciplinary feedback.
- Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification preferred. The ability to become certified within 1 year is required
- Computer literate. Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required. Experience with Microsoft Project is preferred.
- Ability to achieve consistently high results in quality, efficiency, and compliance through individual and team efforts in a high-demand environment.
- Training in Process Excellence/Six Sigma tools and methodologies and Certification preferred.
- Advanced computer and database management skills preferred.
- Statistical and analytical problem solving are preferred.
- Experience in leading and managing projects and milestones preferred.
Preferred:
- Comfortability working in a matrix environment and the ability to connect with different functional groups and people who work in multiple levels while embracing and driving change
- Knowledge of EUMDR regulations
Other:
This position may require up to 10% Domestic travel.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
