Johnson & Johnson MedTech · 7 hours ago
Senior Reg Compliance Specialist
San Jose, CA
Full-time
Onsite
Senior Level
5+ years expJohnson & Johnson MedTech is committed to healthcare innovation, focusing on digital surgery and robotics. The Senior Regulatory Compliance Specialist will maintain a robust compliance program, ensuring adherence to regulatory requirements and company policies while leading audit processes and compliance improvements.
Hospital & Health Care
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
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
Qualification
Required
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
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
Preferred
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
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
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
Company data provided by crunchbase