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Danvers, Massachusetts, United States
Onsite
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Legal & ComplianceJob Sub Function:
Enterprise ComplianceJob Category:
ProfessionalAll Job Posting Locations:
Danvers, Massachusetts, United States of AmericaJob 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 https://www.jnj.com/medtech
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for Senior Specialist Regulatory Compliance.
Purpose: The Senior Specialist, Regulatory Compliance position is responsible for activities executed under the MedTech Regulatory Compliance (MTRC) organisation supporting Abiomed, Danvers, with a primary focus on internal audit execution, regulatory compliance, and audit and inspection readiness.
You will be responsible for:
o Serve as the Lead/Team Auditor for Internal Audits.
o Execute internal audits in accordance with established procedures and requirements.
o Complete internal audit reports within the EtQ system, ensuring adherence to established timelines and documentation requirements.
o Ensure adherence to internal audit schedule for site against established internal audit procedures.
o Drive and maintain FDA inspection readiness following the Warning Letter, working closely with business stakeholders and Bioteknika to identify and close compliance gaps and ensure organisational preparedness for future FDA inspections.
o Partner with business stakeholders and Observation/CAPA owners to drive timely investigation, corrective action, and closure of internal audit observations and CAPAs.
o Provide ongoing internal audit risk and performance reporting through SEA Governance Tier 2 meetings, partnering closely with Abiomed stakeholders and Bioteknika to communicate audit progress, timeliness, ageing, effectiveness, emerging compliance risks, and areas requiring escalation, accountability, or corrective action.
o Maintain a close working partnership with the contractor, BioTeknica, in support of FDA compliance remediation activities, ensuring strong coordination, alignment on priorities and deliverables, timely escalation of issues and risks, and effective follow-through on remediation actions.
o Support all aspects of audit and inspection readiness, including back-room activities, preparation and pre-pull of documentation for anticipated auditor requests, and coordination of supporting evidence.
o Prepare and coach Subject Matter Experts (SMEs) for interactions with auditors and regulatory authorities.
o Provide CAPA coaching and support development of CAPA storyboards to clearly communicate issues, root cause, corrective actions, effectiveness, and supporting evidence.
o Create reports and communicate performance against metrics to cross-functional groups.
o Highlight/communicate adverse trends in metrics and take risk-based action to remediate.
o Responsible for the proactive identification and alerting management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
o Provide internal audit inputs/updates to Quality System Management Reviews to allow meaningful review of their tasks.
o Responsible for communicating business-related issues or opportunities to next management level
o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
o 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
o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
o Performs other duties assigned as needed
Qualifications / Requirements:
o Bachelor’s degree in science, Engineering, Quality, Regulatory Affairs, or a related technical discipline is required.
o A minimum of 10 years of relevant experience within the medical device industry, with demonstrated knowledge of FDA, ISO, NMPA and other applicable Health Authority regulatory and quality-system requirements.
o Demonstrated experience working with Class III medical devices subject to FDA Premarket Approval (PMA) requirements, with an understanding of the heightened regulatory scrutiny, compliance expectations, and risk considerations associated with higher-risk medical devices
o Experience in Quality, Manufacturing, Engineering, Regulatory Compliance, or related functions is required.
o Demonstrated auditing experience, including planning, execution, documentation, reporting, and follow-up of internal audits.
o Experience leading, managing, or providing significant support to an internal audit programme, including monitoring audit progress, timeliness, ageing, effectiveness, and closure of identified issues
o Experience communicating internal audit risk, progress, trends, and performance metrics through governance forums and effectively escalating areas requiring management attention.
o Demonstrated experience supporting regulatory inspection and audit readiness, including identification and closure of compliance gaps, SME preparation and coaching, CAPA coaching, CAPA storyboard development, pre-pull and organisation of documentation, back-room support, GEMBA walks, and inspection logistics.
o Experience supporting FDA compliance remediation activities, including close collaboration with internal stakeholders, external contractors or consultants, and action owners to drive timely and sustainable remediation.
o Experience assessing organisational readiness against evolving regulatory and quality-system requirements, including MDSAP and QMSR, is preferred.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
o Strong written and verbal communication and stakeholder-management skills, with the ability to communicate effectively across technical, quality, regulatory, and leadership audiences.
o Strong ability to influence and collaborate across functions while maintaining clear ownership, accountability, and focus on timely closure of compliance commitments.
o Ability to manage multiple priorities, identify areas requiring escalation, and maintain focus on audit execution, remediation progress, and sustained inspection readiness.
o Ability to translate regulatory and quality-system requirements into practical, sustainable, and implementable solutions.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Audit and Compliance Trends, Audit Management, Audit Reporting, Business Behavior, Business Writing, Coaching, Communication, Compliance Frameworks, Compliance Management, Compliance Risk, Corporate Investigations, Critical Thinking, Legal Function, Legal Services, People Centricity, Problem Solving, Process Improvements
The anticipated base pay range for this position is :
$94,000.00 - $151,800.00Additional 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)).