Johnson & Johnson MedTech · 2 days ago
Staff Regulatory Compliance Specialist
Raritan, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$94K/yr - $152K/yr
6+ years expJohnson & Johnson MedTech is dedicated to health innovation, aiming to provide smarter and less invasive treatments. The Staff Regulatory Compliance Specialist will establish and maintain compliance programs, conduct internal audits, and support regulatory requirements across various sites.
Hospital & Health Care
Responsibilities
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:
This individual will be responsible for Compliance data gathering, data analysis, trending and compiling compliance updates and sharing with Senior leaders within Surgery and MedTech. This individual will also be responsible for the implementation of proactive compliance projects and Initiatives, digital reporting improvements as well as providing compliance support for Quality improvement and remediation activities
Refine, report and communicate compliance opportunities through data insights and analytics across J&J MedTech. Evaluate, Ideate and implement new digital reporting processes Manage reporting process improvements
Lead and manage site inspection readiness activities to ensure inspection readiness at all time. Schedule and handle mock inspections as part of External Inspection Readiness activities. Provide timely information to support the inspection process, including those that may be taking place at other sites / locations
Establish and implement an effective internal audit schedule for site against established internal audit procedures. Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive timely completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure. Where appropriate, execute program(s) for training and evaluating qualifications of auditors. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements
Drive compliance audit metrics and provide required support to ensure they are on track. Create reports and communicate performance against metrics to cross-functional groups. Highlight/communicate adverse trends in metrics and take risk-based action to remediate. Support Field Action assessments
Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. Provide internal audit inputs/updates to Quality System Management Reviews to allow meaningful review of their tasks
Participate in JJRC audits as requested. Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards
Qualification
Required
Bachelor's degree in Scientific or Technical discipline or equivalent is required
A minimum of 6 years of proven experience in medical devices or pharmaceuticals or Biopharmaceuticals (in a Quality, Compliance, Manufacturing, or Operations function) is required
Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry
Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units
Balanced technical understanding of products and processes combined with outstanding business and compliance acumen
High tolerance for ambiguity in a complex environment
Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures
Ability to make the complex clear and easily understood by others
Preferred
An advanced degree is a plus
Knowledge of interpretation and application of 21CFR 210, 211, 800's and 600's, QSR, MDD, MDR and ISO 13485 is preferred
Current certification of quality system auditor or lead auditor preferred
Experience in Data Analysis and reporting is preferred
Intermediate to advance user level in Excel Data analytics (Pivot table and charting) is preferred
Basic Power BI and/or Tableau Capabilities are preferred
Agile Internal Audit
Analytical Reasoning
Audit and Compliance Trends
Compliance Frameworks
Compliance Management
Compliance Policies
Critical Thinking
Process Improvements
Quality Auditing
Quality Control (QC)
Quality Standards
Regulatory Compliance
Risk Compliance
Risk Management
Technical Credibility
Third-Party Auditing
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work
Personal and Family Time - up to 40 hours per calendar year
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
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