Director, Privacy Policy & Operations

DePuy Synthes is recruiting for a Director, Privacy Policy & Operations, located in Raynham, Massachusetts

The Director, Privacy Policy and Operations, provides strategic leadership for the handling and treatment of protected data, including personal data, monitoring, interpreting, and influencing global regulatory policies, standards, and requirements that impact DePuy Synthes products and operations. This role plays a critical enterprise‑level role in ensuring the organization remains prepared and compliant with evolving regulatory expectations for the management of protected data across global markets. The position partners closely with Regulatory Affairs, Quality, R&D, Legal, and industry bodies to translate external regulatory changes into clear internal guidance and actionable strategies. This role has high visibility and direct impact on product compliance, market access, and patient safety. 

Key Responsibilities 

• Lead global regulatory surveillance activities to identify, assess, and communicate emerging regulations, policies, and standards for protected data impacting medical devices and medtech products. 

• Interpret complex regulatory requirements and translate them into clear internal policies, standards, and guidance. 

• Oversee development, maintenance, and governance of privacy, data protection and related cybersecurity policies and standards to ensure alignment with global requirements. 

• Partner with Regulatory Affairs, Quality, R&D, and Legal to assess business impact and define compliance strategies. 

• Represent DePuy Synthes in external industry groups, standards committees, and regulatory forums, as appropriate. 

• Monitor regulatory and enforcement trends and proactively advise leadership on risks, opportunities, and mitigation strategies. 

• Lead, coach, and develop team members or subject‑matter experts supporting regulatory surveillance activities. 

• Support inspections, audits, and regulatory inquiries by providing expert interpretation and documentation. 

Qualifications 

Education 

• Bachelor’s degree required, preferably in Engineering, Life Sciences, Regulatory Affairs, or a related field. 

• Advanced degree (Master’s, PhD) preferred. 

Experience and Skills 

Required 

• Typically requires 8–10 years of progressive experience in regulatory affairs, quality, compliance, or related medical device roles. 

• Demonstrated expertise in global medical device regulations, standards, and policy interpretation. 

• Proven experience assessing regulatory impact and translating requirements into business‑ready guidance. 

• Strong people‑leadership experience, including coaching, mentoring, and performance management. 

Preferred 

• Experience working with FDA, EU MDR/IVDR, ISO standards, and other global regulatory frameworks. 

• Experience representing an organization in industry associations or standards committees. 

• Background in orthopedic or implantable medical devices. 

• Experience supporting regulatory inspections or audits. 

• Familiarity with regulatory intelligence or surveillance tools and systems. 

• Ability to influence senior leaders and cross‑functional stakeholders in a matrixed environment. 

• Strong analytical, communication, and strategic thinking skills. 

Other 

• Language: English proficiency required. Additional languages preferred. 

• Travel: Up to 15–20% domestic and/or international travel. 

• Certifications (preferred): RAC (Regulatory Affairs Certification) or equivalent.