Regulatory Compliance Director, Abiomed at Johnson & Johnson

Danvers, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

Expertise in establishing and maintaining robust Compliance Programs to ensure compliance with local, national, international regulatory requirements, company policies, procedures, and J&J corporate requirements
Ability to lead the Abiomed JJRC team and serve as a member of the J&J Regulatory Compliance team
Capability to collaborate with other groups within the J&J Regulatory Compliance organization for audits, assessments, and compliance initiatives
Cross-functional collaboration skills within Abiomed to support quality, business, and compliance goals

Responsibilities

Prepare and host external audits (e.g., Notified Body, Ministry of Health inspections, FDA, J&J Corporate Audits), including auditor logistics, front/back room arrangements, SME preparation, and effective regulatory agency inspections
Assess risk and applicability of audit observations from other J&J facilities to the site
Schedule and manage mock inspections for External Inspection Readiness
Provide timely information and daily communications on inspections, including potential non-conformities at other sites/locations
Prepare responses to external inspections or regulatory notifications
Ensure adequate corrective actions for external audit observations, including investigations, CAPA plans, on-time completion, follow-up, effectiveness monitoring, and closure
Establish and execute an effective internal audit schedule and procedures for the site
Ensure adequate corrective actions for internal audits, including investigations, CAPA plans, on-time completion, follow-up, effectiveness monitoring, and closure
Drive compliance and improvement in internal audit metrics
Periodically evaluate and audit the quality system, implementing preventive/corrective actions to meet business and regulatory requirements
Execute programs for training and qualifying auditors (potentially including franchise, supply chain, sector, enterprise elements)
Participate in JJRC audits as requested
Represent on required business unit, sector, and/or enterprise teams (e.g., Do it Right, IPREVENT)
Support creation and effective deployment of compliance initiatives

Skills

Regulatory Compliance

FDA Regulations

Notified Body Audits

Compliance Programs

Quality Management

Audits

Inspections

Corporate Governance

Risk Assessment

Cross-functional Collaboration

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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