Principal Reg Compliance Specialist

Johnson & Johnson•San Jose, CA

About The Position

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.

Requirements

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.
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.
Ability to achieve consistently high results in quality, efficiency, and compliance through individual and team efforts in a high-demand environment.

Nice To Haves

Experience with Microsoft Project is preferred.
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

Responsibilities

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.
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.
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.
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.
Escalates items in accordance with established procedures.
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.
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.
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