Director, Privacy Policy & Operations
About The Position
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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 plans. In 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. 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.
Requirements
- Bachelor’s degree required, preferably in Engineering, Life Sciences, Regulatory Affairs, or a related field.
- 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.
- English proficiency required.
Nice To Haves
- Advanced degree (Master’s, PhD) 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.
- Additional languages preferred.
- RAC (Regulatory Affairs Certification) or equivalent.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
