Job Function:
Legal & Compliance
Job Sub Function:
Enterprise Compliance
Job Category:
Professional
All Job Posting Locations:
Danvers, Massachusetts, United States of America, Halethorpe, Maryland, United States of America
Job Description:
About MedTech
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
We are searching for the best talent for Senior Manager Regulatory Compliance role to be located at Danvers, MA or Baltimore, MD.
The position of Senior Regulatory Compliance Manager is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements.
The Senior Regulatory Compliance Manager will be a member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated Abiomed sites and with the Regulatory Compliance teams of other regions and business groups.
The Senior Regulatory Compliance Manager is expected to collaborate with other groups within the J&J Regulatory Compliance (JJRC) organization to support execution of independent audits and special assessments and deploy compliance initiatives.
Key Responsibilities:
Lead and manage site audit readiness activities to always ensure inspection readiness
Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site. Responsible for effective regulatory agency inspections.
Audit preparation activities (auditor logistics, front room/back-room arrangements, identifying/preparing SME’s, etc.).
Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site
Schedule and manage 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.
Provide daily inspection communications regarding potential non-conformities.
Prepare responses to any external inspection or other regulatory notification associated with site.
Ensure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners and perform effectiveness monitoring and closure.
Establish and execute an effective internal audit schedule for site
Execute against established internal audit procedures
Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
Drive compliance and improvement in internal audit metrics
Ensure quality system is periodically evaluated and audited and appropriate preventive/corrective action is taken to meet the business and regulatory requirements
Where appropriate, execute program(s) for training and evaluating qualifications of auditors.
Participate in JJRC audits as requested.
Where appropriate assure representation on all required business unit, sector, and/or enterprise teams
Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards.
Connect and collaborate with other compliance teams
Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
Drive compliance to Quality and Compliance metric targets.
Create reports and communicate performance against metrics to key stakeholders.
Highlight/communicate adverse trends in metrics and take risk-based action to remediate.
Assure that required compliance-related events (e.g., field actions, inspections) are entered in CURVE or equivalent systems per required timeframes.
Assure that information in the above system is current and updated in a timely manner.
Escalate items in accordance with established procedures.
Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.
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.
Proactively assess and influence the external environment by participating on industry and regulatory body work teams. As appropriate collect and provide site input.
Communicate outcomes and trends to key stakeholders.
Support implementation of new external standards/regulations
Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings
Provide input into Quality System Management Reviews (e.g. internal audits) to allow meaningful review their tasks
Proactively communicate organizational and compliance procedure/ policy related changes that may impact sites. Ensure feedback and alignment with said changes.
Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, Manufacturing.
Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
As appropriate, perform annual performance appraisals for identified associates.
Establish objectives and development plans for direct reports
Support and promote the safety and environmental objectives of the facility
Qualifications/requirements:
A minimum of a Bachelor’s degree in science or quality engineering discipline is required.
A minimum of 8 years of related experience including 2-3 years’ specific experience in a management/supervisory role.
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
Proven track record of demonstrating collaboration across the organization and at all levels
Balanced technical understanding of products and processes combined with superior business and compliance acumen
Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results
Ability to recognize, build support for change and engage in constructive conflict.
High tolerance for ambiguity in a complex environment
Ability to make the complex clear and easily understood by others
Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas
Ability to build partnerships both internally and externally
Capacity to put the customer central to all thinking
Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures
Other:
Required Skills:
Preferred Skills:
Audit and Compliance Trends, Audit Findings and Recommendations, Audit Reporting, Compliance Management, Compliance Risk, Confidentiality, Consulting, Controls Compliance, Developing Others, Internal Auditing, Investigation Techniques, Legal Function, Legal Services, Mentorship, Organizing, Policy Development, Tactical Planning, Technical Credibility
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
