Manager, Compliance Risk Mgmt.

DePuy Synthes is recruiting for a(n) Manager Compliance Risk Management located in Raynham MA.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview

The Manager Compliance Risk Management is a Quality Assurance leadership role responsible for identifying assessing and managing compliance risks across DePuy Synthes operations. This role plays a key part in ensuring adherence to quality system requirements and regulatory expectations while enabling business execution. The position partners closely with Quality Regulatory Manufacturing Supply Chain and other crossfunctional teams to proactively manage risk support inspections and strengthen a culture of quality and compliance.

Key Responsibilities

• Lead compliance risk management activities including identification assessment mitigation and monitoring of quality and regulatory risks.

• Develop and maintain risk management processes aligned with quality system and regulatory requirements.

• Partner with crossfunctional teams to integrate riskbased thinking into operational and quality decisionmaking.

• Support internal and external audits and inspections by preparing risk assessments documentation and responses.

• Analyze trends metrics and quality data to identify emerging compliance risks and improvement opportunities.

• Provide guidance and training on compliance risk management principles and quality system expectations.

• Ensure effective documentation and reporting of compliance risks and mitigation actions.

• Drive continuous improvement initiatives to enhance compliance risk processes and overall quality system effectiveness.

• Communicate risk status priorities and recommendations to Quality and business leadership.

Qualifications

Education

• Bachelors degree required in engineering life sciences or a related technical discipline.

• Advanced degree preferred.

Experience and Skills

Required:

• 68 years of progressive experience in Quality Assurance Compliance or Risk Management within a regulated industry (medical device preferred).

• Strong knowledge of quality systems compliance risk management and regulatory expectations.

• Experience supporting audits inspections and compliancerelated activities.

• Demonstrated ability to assess risk analyze data and translate findings into actionable recommendations.

• Proven ability to work effectively in crossfunctional and matrixed environments.

• Strong written and verbal communication skills with the ability to influence and engage stakeholders.

Preferred:

• Experience in medical device quality systems and global regulatory environments.

• Prior people leadership or project leadership experience.

• Experience with risk management tools methodologies and quality metrics.

• Demonstrated success driving continuous improvement initiatives.

• Familiarity with FDA ISO and other applicable quality and regulatory standards.

Other:

• Languages:English required.

• Travel:Moderate primarily domestic.

• Certifications:Quality or compliancerelated certification (e.g. ASQ RAC) preferred.

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