Principal Regulatory Compliance

Principal Regulatory Compliance - Lead Auditor

Join to apply for the Principal Regulatory Compliance role at Johnson & Johnson Med Tech.

This position is based in Danvers, Massachusetts. The Principal Regulatory Compliance Specialist will establish and maintain robust Compliance Programs at designated Abiomed sites, ensuring compliance with local, national, and international regulatory requirements, company policies, procedures and J&J corporate requirements. The Specialist will be part of the Abiomed and J&J Regulatory Compliance teams and will collaborate with Quality Operations leads and Regulatory Compliance teams across regions and business groups.

• Lead and manage site audit readiness activities to ensure inspection readiness at all times. Schedule and handle mock inspections as part of External Inspection Readiness activities. Provide timely information to support the inspection process, including those that may take place at other sites or locations.
• Establish and implement an effective internal audit schedule for each site against established internal audit procedures. Serve as the Lead Auditor for Internal Audits; ensure adequate corrective actions for internal audit observations, including investigations and corrective action plans, drive timely completion of action plans, and perform follow‑up with observation/CAPA owners through closure. Where appropriate, execute programs for training and evaluating qualifications of auditors.
  
  Execute program(s) for franchise, supply chain, sector, and/or enterprise elements. Remediate adverse trends in metrics and take risk‑based action to remediate. Ensure required compliance‑related events (e.g., field actions, inspections) are entered into the appropriate system.
• Proactively identify and alert management to quality issues in time to resolve potential adverse effects to the customer, company image, or reputation.
• Participate in JJRC audits as requested and support the creation and effective deployment of internal J&J Quality System and/or Compliance standards.
• Drive compliance in internal audit metrics, create reports and communicate performance against metrics to cross‑functional groups.

• BA/BS or equivalent is required, with 8–10 years of proven experience in medical device.
• Current certification as a quality system auditor or lead auditor.

• 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 engage executive management to support proactive and reactive measures; ability to make the complex clear and easily understood by others.

Base pay range: $ – $.

Under current guidelines this position is eligible for an annual performance bonus. Bonuses are awarded at the Company's discretion on an individual basis.

• Eligible to participate in employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, and group legal insurance.
• Eligible for the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Time‑off benefits:
  Vacation up to 120 hours per calendar year;
  Sick time up to 40 hours per calendar year (up to 56 hours in Washington);
  Holiday pay, including floating holidays up to 13 days per calendar year;
  Work, personal and family time up to 40 hours per calendar year.
• Additional information can be found at

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 inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact us via  Internal employees may contact AskGS to be directed to your accommodation resource.

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Seniority level:
Not Applicable.

Employment type:

Full‑time.