Staff Regulatory Compliance Specialist

Johnson & Johnson•Raritan, NJ

About The Position

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 We are searching for the best talent for a Staff Regulatory Compliance Specialist to be located in Raritan, NJ. Purpose: The position of the Staff Regulatory Compliance Specialist is responsible for establishing and maintaining robust Compliance Programs at Ethicon Raritan HQ site and will be supporting the other Ethicon sites as needed in order to ensure compliance to local, national and international regulatory requirements, applicable standards, company policies and procedures and J&J corporate requirements. This individual will be responsible for the implementation of proactive compliance projects and Initiatives, conducting Internal audits as part of site Internal Audit program, leading Inspection Readiness activities and supporting external audits, supporting execution of independent audits and special assessments, digital improvements as well as providing compliance support for Quality improvement and remediation activities. This individual will also be responsible for Compliance data gathering, data analysis, trending and compiling compliance updates and sharing the same with Senior leaders within Surgery and MedTech. The Staff Regulatory Compliance Specialist will be a member of the Ethicon and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated Ethicon sites and with the Regulatory Compliance teams of other regions and business groups.

Requirements

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
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.
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.

Nice To Haves

An advanced degree is a plus.

Responsibilities

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.

Benefits

The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
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
Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits