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 cross-functional groups. 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 into the appropriate system.
• 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. 

Qualifications/Requirements:

• BA/BS or equivalent is required, with 8-10 years of proven experience in medical Device.
• 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.
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