Principal Regulatory Compliance Specialist

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 https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Principal Regulatory Compliance Specialist to be located in Danvers, MA.

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.

Purpose: The position of the Principal Regulatory Compliance Specialist is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements.

The Principal Regulatory Compliance Specialist will be a member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated CSS sites and with the Regulatory Compliance teams of other regions and business groups.

The Principal Regulatory Compliance Specialist 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.

You will be responsible for:


* Lead and manage site audit 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 maybe 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 in internal audit metrics.

Create reports and communicate performance against metrics to...